Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-27 @ 9:20 AM
Study NCT ID:
NCT01927120
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2013-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
In Vivo Treg Expansion and Graft-Versus-Host Disease Prophylaxis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007376', 'term': 'Interleukin-2'}, {'id': 'C082598', 'term': 'aldesleukin'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'brian.betts@moffitt.org', 'phone': '813-745-5410', 'title': 'Dr. Brian Betts', 'organization': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Strategies to overcome interference from soluble IL-2 receptor and STAT3-mediated acute GVHD are needed.'}}, 'adverseEventsModule': {'timeFrame': '2 years, 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'GVHD Regimen', 'description': 'Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).', 'otherNumAtRisk': 20, 'otherNumAffected': 4, 'seriousNumAtRisk': 20, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hepatobiliary disorders - Other, portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Colonic hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hepatobiliary disorders - Other, VOD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and infestations - Other, pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and infestations - Other, staphylococcus epidermis bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Intracranial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cystitis non-infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Renal and urinary disorders - Other, adenovirus cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Renal and urinary disorders - Other, kidney stones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Regulatory T Cells (Tregs)/Total CD4+ Cells at Day 30 Post-HCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GVHD Regimen', 'description': 'Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).'}], 'classes': [{'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '39.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days post HCT', 'description': 'Percentage of Treg among blood CD4+ T cells at day 30 after hematopoietic cell transplantation (HCT), to compare to SIR/TAC alone data from a previous trial (median of 16%). The study was designed to capture an increase in regulatory T cells from a median of 16.0% at day +30.', 'unitOfMeasure': 'percentage of CD4+Tregs', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants.'}, {'type': 'SECONDARY', 'title': 'Overall Survival at Day +365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GVHD Regimen', 'description': 'Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).'}], 'classes': [{'categories': [{'measurements': [{'value': '77.1', 'groupId': 'OG000', 'lowerLimit': '49.3', 'upperLimit': '90.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '365 days post HCT', 'description': 'Overall survival will be defined as the time from transplant date to death from any cause.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GVHD Regimen', 'description': 'Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).'}], 'classes': [{'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '63.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year post HCT', 'description': 'Incidence of primary disease relapse per standard definitions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Grade II-IV Acute GVHD by Day +100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GVHD Regimen', 'description': 'Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '63.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '100 days post HCT', 'description': 'Acute GVHD will be graded per the 1995 consensus guidelines.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants.'}, {'type': 'SECONDARY', 'title': 'Cumulative Incidence of Chronic GVHD by Day +365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GVHD Regimen', 'description': 'Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).'}], 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '36.1', 'upperLimit': '79.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '365 days post HCT', 'description': 'Cumulative incidence of chronic GVHD by day +365 per NIH Consensus criteria.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants.'}, {'type': 'SECONDARY', 'title': 'Incidence of Non-relapse Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GVHD Regimen', 'description': 'Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '65.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '365 days post HCT', 'description': 'Incidence of Non-relapse death/Transplant-related mortality. Non-relapse death is defined as death in continuous remission from primary disease requiring transplantation.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants.'}, {'type': 'SECONDARY', 'title': 'Incidence of Unexpected or Serious Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GVHD Regimen', 'description': 'Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).'}], 'classes': [{'title': 'VOD, possibly related', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Portal vein thrombosis, possibly related', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Sepsis, unlikely to be related', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'GI bleed, unrelated', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Acute kidney injury, unrelated', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Kidney stone, unrelated', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Intracranial hemorrhage, unrelated', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to days 130 post HCT', 'description': 'Grade 3-5 unexpected or serious adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.03) were captured up to day +130 or 30 days after the last dose of IL-2. Events listed, with causality in relation to study treatment noted.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants.'}, {'type': 'SECONDARY', 'title': 'Proportion of Treg Among Blood CD4+ T Cells at Day +90 After HCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GVHD Regimen', 'description': 'Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.212', 'groupId': 'OG000', 'lowerLimit': '0.079', 'upperLimit': '0.605'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '90 days post HCT', 'description': 'The proportion of Tregs to non-Treg CD4+ cells to be assessed at day +90. Natural Killer Cells (NKs): Median K/uL NK cells.', 'unitOfMeasure': 'K/uL NK cells', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants.'}, {'type': 'SECONDARY', 'title': 'STAT3, STAT5 (Y694), and S6 Phosphorylation Among Treg and Non-Treg at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GVHD Regimen', 'description': 'Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).'}], 'classes': [{'title': 'pSTAT3', 'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '99.7'}]}]}, {'title': 'pSTAT5', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '99.9'}]}]}, {'title': 'pS6', 'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '41.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days post HCT', 'description': 'Phosphorylation (p): pSTAT3, pSTAT5 (Y694), and pS6 among Treg and non-Treg at day +30.', 'unitOfMeasure': 'percentage in total CD4s', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants.'}, {'type': 'SECONDARY', 'title': 'STAT3, STAT5 (Y694), and S6 Phosphorylation Among Treg and Non-Treg at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GVHD Regimen', 'description': 'Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).'}], 'classes': [{'title': 'pSTAT3', 'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000', 'lowerLimit': '2.56', 'upperLimit': '61.8'}]}]}, {'title': 'pSTAT5', 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000', 'lowerLimit': '33.6', 'upperLimit': '100'}]}]}, {'title': 'pS6', 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000', 'lowerLimit': '0.91', 'upperLimit': '26.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '90 days post HCT', 'description': 'Phosphorylation (p): pSTAT3, pSTAT5 (Y694), and pS6 among Treg and non-Treg at day +90.', 'unitOfMeasure': 'percentage in total CD4s', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Function of Blood Treg After Allogeneic HSCT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GVHD Regimen', 'description': 'Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).'}], 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'spread': '11.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 days post HCT', 'description': 'Percent of Treg suppression at day +30. Investigators had also planned to test Treg function at day +90, if sufficient Tregs had been available for analysis.', 'unitOfMeasure': 'percentage of suppression', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable participants at day +30.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rate of Natural Killer Cell (NK) Reconstitution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GVHD Regimen', 'description': 'Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).'}], 'timeFrame': '365 days post HCT', 'description': 'Investigators planned to monitor natural killer cell (NK) reconstitution. Standard immune deficiency flow cytometry panels (IDP) was to be drawn on days +90, +180, and +365 to evaluate NK reconstitution. Results of standard lab tests to be compared to compiled data at a later date', 'reportingStatus': 'POSTED', 'populationDescription': 'Lab test results to be compared to compiled data at a later date.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GVHD Regimen', 'description': 'Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'Participants were enrolled at Moffitt Cancer Center, April 2014 through December 2015.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'GVHD Regimen', 'description': 'Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '70'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-01', 'studyFirstSubmitDate': '2013-08-16', 'resultsFirstSubmitDate': '2017-04-18', 'studyFirstSubmitQcDate': '2013-08-19', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-01', 'studyFirstPostDateStruct': {'date': '2013-08-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Function of Blood Treg After Allogeneic HSCT', 'timeFrame': '30 days post HCT', 'description': 'Percent of Treg suppression at day +30. Investigators had also planned to test Treg function at day +90, if sufficient Tregs had been available for analysis.'}, {'measure': 'Rate of Natural Killer Cell (NK) Reconstitution', 'timeFrame': '365 days post HCT', 'description': 'Investigators planned to monitor natural killer cell (NK) reconstitution. Standard immune deficiency flow cytometry panels (IDP) was to be drawn on days +90, +180, and +365 to evaluate NK reconstitution. Results of standard lab tests to be compared to compiled data at a later date'}], 'primaryOutcomes': [{'measure': 'Regulatory T Cells (Tregs)/Total CD4+ Cells at Day 30 Post-HCT', 'timeFrame': '30 days post HCT', 'description': 'Percentage of Treg among blood CD4+ T cells at day 30 after hematopoietic cell transplantation (HCT), to compare to SIR/TAC alone data from a previous trial (median of 16%). The study was designed to capture an increase in regulatory T cells from a median of 16.0% at day +30.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival at Day +365', 'timeFrame': '365 days post HCT', 'description': 'Overall survival will be defined as the time from transplant date to death from any cause.'}, {'measure': 'Cumulative Incidence of Relapse', 'timeFrame': '1 year post HCT', 'description': 'Incidence of primary disease relapse per standard definitions.'}, {'measure': 'Cumulative Incidence of Grade II-IV Acute GVHD by Day +100', 'timeFrame': '100 days post HCT', 'description': 'Acute GVHD will be graded per the 1995 consensus guidelines.'}, {'measure': 'Cumulative Incidence of Chronic GVHD by Day +365', 'timeFrame': '365 days post HCT', 'description': 'Cumulative incidence of chronic GVHD by day +365 per NIH Consensus criteria.'}, {'measure': 'Incidence of Non-relapse Death', 'timeFrame': '365 days post HCT', 'description': 'Incidence of Non-relapse death/Transplant-related mortality. Non-relapse death is defined as death in continuous remission from primary disease requiring transplantation.'}, {'measure': 'Incidence of Unexpected or Serious Adverse Events (AEs)', 'timeFrame': 'Up to days 130 post HCT', 'description': 'Grade 3-5 unexpected or serious adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.03) were captured up to day +130 or 30 days after the last dose of IL-2. Events listed, with causality in relation to study treatment noted.'}, {'measure': 'Proportion of Treg Among Blood CD4+ T Cells at Day +90 After HCT', 'timeFrame': '90 days post HCT', 'description': 'The proportion of Tregs to non-Treg CD4+ cells to be assessed at day +90. Natural Killer Cells (NKs): Median K/uL NK cells.'}, {'measure': 'STAT3, STAT5 (Y694), and S6 Phosphorylation Among Treg and Non-Treg at Day 30', 'timeFrame': '30 days post HCT', 'description': 'Phosphorylation (p): pSTAT3, pSTAT5 (Y694), and pS6 among Treg and non-Treg at day +30.'}, {'measure': 'STAT3, STAT5 (Y694), and S6 Phosphorylation Among Treg and Non-Treg at Day 90', 'timeFrame': '90 days post HCT', 'description': 'Phosphorylation (p): pSTAT3, pSTAT5 (Y694), and pS6 among Treg and non-Treg at day +90.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GVHD', 'Allogeneic', 'Hematopoietic Cell Transplant'], 'conditions': ['Graft-Versus-Host-Disease']}, 'referencesModule': {'references': [{'pmid': '28104702', 'type': 'DERIVED', 'citation': 'Betts BC, Pidala J, Kim J, Mishra A, Nishihori T, Perez L, Ochoa-Bayona JL, Khimani F, Walton K, Bookout R, Nieder M, Khaira DK, Davila M, Alsina M, Field T, Ayala E, Locke FL, Riches M, Kharfan-Dabaja M, Fernandez H, Anasetti C. IL-2 promotes early Treg reconstitution after allogeneic hematopoietic cell transplantation. Haematologica. 2017 May;102(5):948-957. doi: 10.3324/haematol.2016.153072. Epub 2017 Jan 19.'}], 'seeAlsoLinks': [{'url': 'http://www.moffitt.org', 'label': 'H. Lee Moffitt Cancer Center \\& Research Institute'}, {'url': 'http://www.haematologica.org/content/early/2017/01/19/haematol.2016.153072.long', 'label': 'IL-2 promotes early Treg reconstitution after allogeneic hematopoietic cell transplantation'}]}, 'descriptionModule': {'briefSummary': 'IL-2 add-back post allogeneic hematopoietic stem cell transplant (HSCT), combined with Sirolimus (SIR), Tacrolimus (TAC) will optimize Treg reconstitution and prevent graft versus host disease (GVHD).', 'detailedDescription': '1\\) Determine if a GVHD prophylaxis regimen of IL-2/SIR/TAC enhances in vivo Treg differentiation and growth; 2) Study the safety and effects of IL-2/SIR/TAC on the incidence of acute and chronic GVHD; 3) Evaluate the influence of dual IL-2 supplementation and mammalian target of rapamycin (mTOR) inhibition on T cell-specific signaling pathways and the polarization of emerging T helper cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must have an available 8/8 human leukocyte antigen (HLA)-A, -B, -C, and -DRB1 matched-related or unrelated donor allogeneic hematopoietic peripheral blood stem cell graft.\n* Acute myeloid leukemia, myelodysplasia, acute lymphoblastic leukemia, chronic myeloid leukemia, or myeloproliferative neoplasms requiring a matched allogeneic HSCT.\n\n * Acute Leukemia (AML or ALL) must be in complete remission defined as: \\<5% marrow blasts with no morphologic evidence of leukemia, no peripheral blasts, marrow \\>20% cellular, and peripheral absolute neutrophil count \\>1000/µL (platelet recovery is not required).\n * Myelodysplasia (MDS) and chronic myeloid leukemia (CML): Must have \\<5% marrow blasts.\n * Myeloproliferative neoplasms (MPN): Must have \\<5% peripheral / marrow blasts.\n* Adequate vital organ function:\n\n 1. Left ventricular ejection fraction (LVEF) ≥ 45% by multi gated acquisition (MUGA) scan or ECHO\n 2. Forced expiratory volume at one second (FEV1), forced vital capacity (FVC), and adjusted diffusing lung capacity oxygenation (DLCO) ≥ 50% of predicted values on pulmonary function tests\n 3. Transaminases (AST, ALT) \\< 2 times upper limit of normal values\n 4. Creatinine clearance ≥ 50 cc/min.\n* Performance status: Karnofsky Performance Status Score ≥ 80%\n* Donor eligibility: Eligible donors will include healthy sibling, relative or unrelated donors that are matched with the patient at HLA-A, B, C, and DRB1 by high resolution typing.\n\nExclusion Criteria:\n\n* Active infection not controlled with appropriate antimicrobial therapy\n* History of HIV, hepatitis B, or hepatitis C infection\n* Anti-thymocyte globulin, alemtuzumab, bortezomib, or cyclophosphamide administered within 14 days before or planned to receive with HCT conditioning or as part of GVHD prophylaxis in the 14 days after HCT.\n* Hypersensitivity to recombinant human IL-2\n* Chronic lymphocytic leukemia, Hodgkin lymphoma, and non-hodgkin lymphoma are excluded as these malignancies may express the IL-2 receptor and pose a potential growth signal to any present disease.\n* Sorror's co-morbidity factors with total score \\>4"}, 'identificationModule': {'nctId': 'NCT01927120', 'briefTitle': 'In Vivo Treg Expansion and Graft-Versus-Host Disease Prophylaxis', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'In Vivo Treg Expansion and Graft-Versus-Host Disease Prophylaxis With IL-2, Sirolimus, and Tacrolimus Following Allogeneic Hematopoietic Cell Transplantation', 'orgStudyIdInfo': {'id': 'MCC-17578'}, 'secondaryIdInfos': [{'id': 'NCI-2014-00755', 'type': 'OTHER', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GVHD Regimen', 'description': 'Graft versus host disease (GVHD) prophylaxis regimen IL-2 with Sirolimus and Tacrolimus after allogeneic hematopoietic cell transplant (HCT).', 'interventionNames': ['Drug: IL-2', 'Drug: Tacrolimus', 'Drug: Sirolimus']}], 'interventions': [{'name': 'IL-2', 'type': 'DRUG', 'otherNames': ['Proleukin®', '(aldesleukin)'], 'description': 'A subcutaneous injection will be administered 3 times a week (separated by at least 1 day between injections), from day 0 to +90 (+/- 7 days).', 'armGroupLabels': ['GVHD Regimen']}, {'name': 'Tacrolimus', 'type': 'DRUG', 'description': 'Will be administered at 0.01 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3', 'armGroupLabels': ['GVHD Regimen']}, {'name': 'Sirolimus', 'type': 'DRUG', 'otherNames': ['Rapamune'], 'description': 'Orally on day -1. The dose for loading is 12 mg by mouth (PO)', 'armGroupLabels': ['GVHD Regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Brian Betts, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}