Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT02500550
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2015-07-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Two Doses of ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted of Host Alloreactive T-cells, in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Israel', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a.sandler@kiadis.com', 'phone': '+1 206 779 9213', 'title': 'Andrew Sandler, MD / Chief Medical Officer', 'organization': 'Kiadis Pharma Netherlands B.V.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The median follow-up time of ATIR101-treated patients in the study was 11.6 (range 2.7-12.8) months after hematopoietic stem cell transplantation (HSCT) .', 'eventGroups': [{'id': 'EG000', 'title': 'ATIR101', 'description': 'ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).\n\nHaploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:\n\n* Total Body Irradiation (TBI) regime\n* Non-TBI regime\n\n(See below for details)\n\nTBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)\n\n* Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.\n\nNon-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4\n\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1\n* ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 8, 'seriousNumAtRisk': 15, 'deathsNumAffected': 7, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Acute GVHD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 7}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Chronic GVHD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Cytomegalovirus (CMV) positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}], 'seriousEvents': [{'term': 'Acute graft-versus-host disease (GVHD)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}, {'term': 'Chronic GVHD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Acute Graft Versus Host Disease (GVHD) Grade III/IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ATIR101', 'description': 'ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).\n\nHaploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:\n\n* Total Body Irradiation (TBI) regime\n* Non-TBI regime\n\n(See below for details)\n\nTBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)\n\n* Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.\n\nNon-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4\n\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1\n* ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.'}], 'classes': [{'title': 'Single dose of ATIR101, grade III/IV acute GVHD within 180 days after HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Two doses of ATIR101, Grade III/IV acute GVHD within 180 days after HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '180 days post HSCT', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary study endpoint, grade III/IV acute GVHD within 180 days after HSCT, was met for two patients treated with two doses of ATIR101.\n\nTwo patients developed grade III/IV acute GVHD within 180 days after HSCT treated with a single dose of ATIR101.'}, {'type': 'SECONDARY', 'title': 'Incidence and Severity of Acute and Chronic GVHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ATIR101', 'description': 'ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).\n\nHaploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:\n\n* Total Body Irradiation (TBI) regime\n* Non-TBI regime\n\n(See below for details)\n\nTBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)\n\n* Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.\n\nNon-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4\n\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1\n* ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.'}], 'classes': [{'title': 'Single dose group acute GVHD between 6 and 12 months after HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Double dose group acute GVHD between 6 and 12 months after HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Single dose group chronic GVHD between 6 and 12 months after HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Double dose group chronic GVHD between 6 and 12 months after HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between 6 and 12 months after HSCT', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '7 patients in the single dose and 4 patients in the double dose were analysed to make a total of 11 patients analysed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved T-Cell Reconstitution at 6 and 12 Months Post HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ATIR101', 'description': 'ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).\n\nHaploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:\n\n* Total Body Irradiation (TBI) regime\n* Non-TBI regime\n\n(See below for details)\n\nTBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)\n\n* Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.\n\nNon-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4\n\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1\n* ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.'}], 'classes': [{'title': 'Cumulative incidence estimates of T-cell reconstitution, 6 months post HSCT. Single dose group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '74.2'}]}]}, {'title': 'Cumulative incidence estimates of T-cell reconstitution, 6 months post HSCT. Double dose group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '82.6'}]}]}, {'title': 'Cumulative incidence estimates of T-cell reconstitution, 12 months post HSCT. Single dose group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '32.7', 'upperLimit': '94.5'}]}]}, {'title': 'Cumulative incidence estimates of T-cell reconstitution, 12 months post HSCT. Double dose group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '82.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 and 12 months post HSCT', 'description': 'Defined as CD3+ in peripheral blood higher than 0.2×10E9/L at 6 and 12 months post HSCT.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Cumulative incidence estimates of T-cell reconstitution at 6 and 12 months post HSCT were analyzed for the single dose group (N=9) and double dose group (N=6).'}, {'type': 'SECONDARY', 'title': 'Viral, Fungal, and Bacterial Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ATIR101', 'description': 'ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).\n\nHaploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:\n\n* Total Body Irradiation (TBI) regime\n* Non-TBI regime\n\n(See below for details)\n\nTBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)\n\n* Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.\n\nNon-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4\n\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1\n* ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.'}], 'classes': [{'title': 'Any infection', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Severity, grade 1-2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Severity, grade 3-5', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 6 months to 1 year after HSCT', 'description': 'Infection was defined as (1) a clinically apparent infectious disease with symptoms or (2) a viral reactivation. Severity was graded according to CTCAE vs. 4.0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Transplant-related Mortality (TRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ATIR101', 'description': 'ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).\n\nHaploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:\n\n* Total Body Irradiation (TBI) regime\n* Non-TBI regime\n\n(See below for details)\n\nTBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)\n\n* Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.\n\nNon-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4\n\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1\n* ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.'}], 'classes': [{'title': 'Single-dose group, cumulative estimates of TRM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '53.3'}]}]}, {'title': 'Double-dose group, cumulative estimates of TRM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '12.2', 'upperLimit': '92.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months post HSCT', 'description': 'Defined as death due to causes other than disease relapse or progression, or other causes which are unrelated to the transplantation procedure (e.g. accident, suicide)', 'unitOfMeasure': 'percentage of participants that died', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Nine participants received a single dose of ATIR101 and 6 participants received a double dose of ATIR101'}, {'type': 'SECONDARY', 'title': 'Relapse-related Mortality (RRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ATIR101', 'description': 'ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).\n\nHaploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:\n\n* Total Body Irradiation (TBI) regime\n* Non-TBI regime\n\n(See below for details)\n\nTBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)\n\n* Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.\n\nNon-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4\n\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1\n* ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.'}], 'classes': [{'title': 'Single dose group, cumulative estimates of RRM 12 months post HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '40.9'}]}]}, {'title': 'Double dose group, cumulative estimates of RRM 12 months post HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months post HSCT', 'description': 'Defined as death due to disease relapse or disease progression', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Nine participants received a single dose of ATIR101 and 6 participants received a double dose of ATIR101'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ATIR101', 'description': 'ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).\n\nHaploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:\n\n* Total Body Irradiation (TBI) regime\n* Non-TBI regime\n\n(See below for details)\n\nTBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)\n\n* Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.\n\nNon-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4\n\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1\n* ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.'}], 'classes': [{'title': 'Single dose group, Kaplan-Meier estimates of OS 12 months post HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '28.2', 'upperLimit': '87.8'}]}]}, {'title': 'Double dose group, Kaplan-Meier estimates of OS 12 months post HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '67.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months post HSCT', 'description': 'Defined as the time from HSCT until death from any cause', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Nine participants received a single dose of ATIR101 and 6 participants received a double dose of ATIR101'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ATIR101', 'description': 'ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).\n\nHaploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:\n\n* Total Body Irradiation (TBI) regime\n* Non-TBI regime\n\n(See below for details)\n\nTBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)\n\n* Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.\n\nNon-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4\n\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1\n* ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.'}], 'classes': [{'title': 'Single dose group, Kaplan-Meier estimates of PFS 12 months post HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '20.4', 'upperLimit': '80.5'}]}]}, {'title': 'Double dose group, Kaplan-Meier estimates of PFS 12 months post HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '67.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months post HSCT', 'description': 'Defined as the time from HSCT until relapse, disease progression, or death, whichever occurs first', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Nine participants received a single dose of ATIR101 and 6 participants received a double dose of ATIR101'}, {'type': 'SECONDARY', 'title': 'GVHD-free, Relapse-free Survival (GRFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ATIR101', 'description': 'ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).\n\nHaploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:\n\n* Total Body Irradiation (TBI) regime\n* Non-TBI regime\n\n(See below for details)\n\nTBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)\n\n* Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.\n\nNon-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4\n\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1\n* ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.'}], 'classes': [{'title': 'Single dose, Kaplan-Meier estimates of GRFS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '20.4', 'upperLimit': '80.5'}]}]}, {'title': 'Double dose, Kaplan-Meier estimates of GRFS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '51.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months post HSCT', 'description': 'Defined as the time until acute GVHD grade III/IV, chronic GVHD requiring systemic treatment, relapse, or death, whichever occurs first', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Nine subjects received a single dose of ATIR101 and 6 subjects received a double dose of ATIR101.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ATIR101', 'description': 'ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).\n\nHaploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:\n\n* Total Body Irradiation (TBI) regime\n* Non-TBI regime\n\n(See below for details)\n\nTBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)\n\n* Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.\n\nNon-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4\n\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1\n* ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ATIR101', 'description': 'ATIR101: T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).\n\nHaploidentical hematopoietic stem cell transplantation (HSCT): CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:\n\n* Total Body Irradiation (TBI) regime\n* Non-TBI regime\n\n(See below for details)\n\nTBI regime: • Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)\n\n* Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.\n\nNon-TBI regime: • Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4\n\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1\n* ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '71'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-11-20', 'size': 1216816, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-01T08:02', 'hasProtocol': True}, {'date': '2018-12-13', 'size': 746094, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-12-01T08:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'dispFirstSubmitDate': '2019-08-19', 'completionDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-17', 'studyFirstSubmitDate': '2015-07-14', 'dispFirstSubmitQcDate': '2019-08-19', 'resultsFirstSubmitDate': '2020-12-17', 'studyFirstSubmitQcDate': '2015-07-14', 'dispFirstPostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-17', 'studyFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Acute Graft Versus Host Disease (GVHD) Grade III/IV', 'timeFrame': '180 days post HSCT'}], 'secondaryOutcomes': [{'measure': 'Incidence and Severity of Acute and Chronic GVHD', 'timeFrame': 'Between 6 and 12 months after HSCT'}, {'measure': 'Percentage of Participants Who Achieved T-Cell Reconstitution at 6 and 12 Months Post HSCT', 'timeFrame': '6 and 12 months post HSCT', 'description': 'Defined as CD3+ in peripheral blood higher than 0.2×10E9/L at 6 and 12 months post HSCT.'}, {'measure': 'Viral, Fungal, and Bacterial Infections', 'timeFrame': 'From 6 months to 1 year after HSCT', 'description': 'Infection was defined as (1) a clinically apparent infectious disease with symptoms or (2) a viral reactivation. Severity was graded according to CTCAE vs. 4.0'}, {'measure': 'Transplant-related Mortality (TRM)', 'timeFrame': '12 months post HSCT', 'description': 'Defined as death due to causes other than disease relapse or progression, or other causes which are unrelated to the transplantation procedure (e.g. accident, suicide)'}, {'measure': 'Relapse-related Mortality (RRM)', 'timeFrame': '12 months post HSCT', 'description': 'Defined as death due to disease relapse or disease progression'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '12 months post HSCT', 'description': 'Defined as the time from HSCT until death from any cause'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': '12 months post HSCT', 'description': 'Defined as the time from HSCT until relapse, disease progression, or death, whichever occurs first'}, {'measure': 'GVHD-free, Relapse-free Survival (GRFS)', 'timeFrame': '12 months post HSCT', 'description': 'Defined as the time until acute GVHD grade III/IV, chronic GVHD requiring systemic treatment, relapse, or death, whichever occurs first'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Haploidentical stem cell transplantation', 'Graft versus host disease', 'Immune reconstitution', 'Alloreactive T-cells', 'Photodynamic treatment', 'Hematologic malignancy', 'Transplant-related mortality'], 'conditions': ['Acute Myeloid Leukemia', 'Acute Lymphoblastic Leukemia', 'Myelodysplastic Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a repeat dose administration of ATIR101 is safe and effective when infused in patients with a hematologic malignancy following a T-cell depleted stem cell graft from a related haploidentical donor. All patients are planned to receive two ATIR101 doses of 2×10E6 viable T-cells/kg, unless the second dose is reduced or halted for safety reasons.', 'detailedDescription': 'Study CR-AIR-008 is an exploratory, open-label, multicenter study. After signing informed consent, patients will receive a hematopoietic stem cell transplantation (HSCT) from a related, haploidentical donor, followed by a first ATIR101 infusion at a dose of 2×10E6 viable T-cells/kg between 28 and 32 days after the HSCT. Patients will receive a second ATIR101 infusion at a dose of 2×10E6 viable T-cells/kg between 70 and 74 days after the HSCT. To evaluate safety of the second dose administration, the first 6 patients treated will be evaluated for the occurrence of dose limiting toxicity (DLT), defined as acute GvHD grade III/IV within 120 days post HSCT (or within 42 days after the second ATIR101 infusion in case of prior dose delays). If within the first 6 patients no DLT is observed, treatment of the remaining 9 patients will continue with two ATIR101 doses of 2×10E6 viable T cells/kg. If within the first 6 patients at least 2 patients show DLT, the second ATIR101 infusion will be adjusted to a dose of 1×10E6 viable T cells/kg. If in one of the next 3 patients treated at this lower dose again DLT is observed, the second ATIR101 infusion will be halted and the remaining patients will be given only a single dose of ATIR101.\n\nAll patients treated with ATIR101 will be followed up until 12 months after the HSCT. Assessments will be performed at weekly visits from the day of the first ATIR101 infusion (Week 4) until 6 weeks after the second ATIR101 infusion (Week 16), at monthly visits from 4 until 6 months after the HSCT, and every 3 months from 6 until 12 months after the HSCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any of the following hematologic malignancies:\n\n * Acute myeloid leukemia (AML) in first remission with high-risk features or in second or higher remission\n * Acute lymphoblastic leukemia (ALL) in first remission with high-risk features or in second or higher remission\n * Myelodysplastic syndrome (MDS): transfusion-dependent, or intermediate or higher IPSS-R risk group\n* Karnofsky performance status ≥ 70%\n* Eligible for haploidentical stem cell transplantation according to the investigator\n* Male or female, age ≥ 18 years and ≤ 65 years\n\nExclusion Criteria:\n\n* Availability of a fully matched related or unrelated donor following a donor search\n* Diffusing capacity for carbon monoxide (DLCO) \\< 50% predicted\n* Left ventricular ejection fraction \\< 50% (evaluated by echocardiogram or MUGA)\n* AST \\> 2.5 x ULN (CTCAE grade 2)\n* Bilirubin \\> 1.5 x ULN (CTCAE grade 2)\n* Creatinine clearance \\< 50 mL/min (calculated or measured)\n* Positive HIV test\n* Positive pregnancy test (women of childbearing age only)\n* Prior allogeneic HSCT\n* Estimated probability of surviving less than 3 months\n* Known allergy to any of the components of ATIR101 (e.g., dimethyl sulfoxide)\n* Known presence of HLA antibodies against the non-shared donor haplotype\n* Any other condition which, in the opinion of the investigator, makes the patient ineligible for the study\n\nInclusion Criteria Donor:\n\n* Haploidentical family donor with 2 to 3 mismatches at the HLA-A, -B and/or -DR loci of the unshared haplotype\n* Male or female, age ≥ 16 and ≤ 75 years (If applicable, local legal requirements for donors under the age of 18 will be followed)\n* Eligible for donations of human blood and blood components according to local requirements and regulations\n* Eligible for donation according to the transplantation center\n\nExclusion Criteria Donor:\n\n* Positive pregnancy test or nursing (women of childbearing age only)\n* Positive viral test for HIV-1, HIV-2, HBV, HCV, Treponema pallidum, HTLV 1 (if tested), HTLV-2 (if tested), or WNV (if tested)'}, 'identificationModule': {'nctId': 'NCT02500550', 'briefTitle': 'Safety and Efficacy of Two Doses of ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted of Host Alloreactive T-cells, in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kiadis Pharma'}, 'officialTitle': 'An Exploratory, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of a Two-dose Regimen of ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells (Using Photodynamic Treatment), in Patients With a Hematologic Malignancy, Who Received a CD34-selected Hematopoietic Stem Cell Transplantation From a Haploidentical Donor', 'orgStudyIdInfo': {'id': 'CR-AIR-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ATIR101', 'interventionNames': ['Biological: ATIR101', 'Procedure: Haploidentical hematopoietic stem cell transplantation (HSCT)', 'Procedure: TBI regime', 'Procedure: Non-TBI regime']}], 'interventions': [{'name': 'ATIR101', 'type': 'BIOLOGICAL', 'description': 'T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).', 'armGroupLabels': ['ATIR101']}, {'name': 'Haploidentical hematopoietic stem cell transplantation (HSCT)', 'type': 'PROCEDURE', 'description': 'CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:\n\n* Total Body Irradiation (TBI) regime\n* Non-TBI regime\n\n(See below for details)', 'armGroupLabels': ['ATIR101']}, {'name': 'TBI regime', 'type': 'PROCEDURE', 'description': '* Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)\n* Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.', 'armGroupLabels': ['ATIR101']}, {'name': 'Non-TBI regime', 'type': 'PROCEDURE', 'description': '* Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4\n* Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7\n* Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1\n* ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV.', 'armGroupLabels': ['ATIR101']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Sint-Jan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire de Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': 'L8V 1C3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Juravinski Hospital and Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Maisonneuve-Rosemont Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'University Hospital Centre Zagreb', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'University Medical Center Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '1649-028', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital de Santa Maria, Clinica Universitaria Hematologia', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': 'B9 5SS', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Heartlands Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'W12 ONN', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Denis Claude Roy, Prof MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maisonneuve-Rosemont Hospital (Montreal, Canada)'}, {'name': 'Stephan Mielke, Prof MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Allogeneic Stem Cell Transplantation, Karolinska University Hospital (Stockholm, Sweden)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kiadis Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}