Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-06-16 @ 7:49 AM
Study NCT ID:
NCT02859402
Status:
RECRUITING
Last Update Posted:
2022-08-18
First Post:
2016-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D054391', 'term': 'Lymphoma, Extranodal NK-T-Cell'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002066', 'term': 'Busulfan'}, {'id': 'C024352', 'term': 'fludarabine'}], 'ancestors': [{'id': 'D002072', 'term': 'Butylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008698', 'term': 'Mesylates'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-17', 'studyFirstSubmitDate': '2016-08-04', 'studyFirstSubmitQcDate': '2016-08-08', 'lastUpdatePostDateStruct': {'date': '2022-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year progression-free survival', 'timeFrame': '2 years', 'description': '2 year progression-free survival rate from the date of allogeneic stem cell transplantation. Estimated using the Kaplan-Meier method. Median value will be provided.'}], 'secondaryOutcomes': [{'measure': 'Response rate', 'timeFrame': '3-months', 'description': 'Response will be measured after 3 months of the date of allogeneic stem cell transplantation. Mean value will be provided.'}, {'measure': 'Time to neutrophil engraftment', 'timeFrame': 'Day 30', 'description': 'Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.'}, {'measure': 'Time to platelet engraftment', 'timeFrame': 'Day 30', 'description': 'Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.'}, {'measure': '2-year overall survival', 'timeFrame': '2 years', 'description': '2 year overall survival rate from the date of allogeneic stem cell transplantation. Estimated using the Kaplan-Meier method. Median value will be provided.'}, {'measure': '100-days treatment-related mortality', 'timeFrame': 'Days 100', 'description': 'Summarized using standard descriptive statistics.'}, {'measure': 'Rate of regimen-related toxicities', 'timeFrame': 'Day 30', 'description': 'Toxicity according to CTCAE version 4.03. Summarized using standard descriptive statistics.'}, {'measure': 'Rate of hepatic venoocclusive disease (HVOD)', 'timeFrame': 'Day 30', 'description': 'Summarized using standard descriptive statistics.'}, {'measure': 'Acute graft-versus-host disease (GVHD) grades I-IV', 'timeFrame': 'Day 100', 'description': 'Summarized using standard descriptive statistics.'}, {'measure': 'Chronic GVHD grades I-IV', 'timeFrame': '2 year', 'description': 'Summarized using standard descriptive statistics.'}, {'measure': 'Rate of cytomegalovirus (CMV) infection', 'timeFrame': '2 year', 'description': 'Summarized using standard descriptive statistics.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['T-cell Non-Hodgkin Lymphoma', 'NK/T-cell Non-Hodgkin Lymphoma', 'Relapsed, refractory', 'Conditioning', 'Allogeneic stem cell transplantation'], 'conditions': ['T-cell Non-Hodgkin Lymphoma', 'Lymphoma, Extranodal NK-T-Cell']}, 'descriptionModule': {'briefSummary': 'Relapsed and refractory T-cell lymphomas have been reported to have dismal outcomes. The role of allogeneic stem cell transplantation have been demonstrated in these patients. This clinical trial is studying the efficacy and safety of busulfan plus fludarabine as conditioning therapy followed by allogeneic stem cell transplantation (Allo-SCT) in T- and NK/T-cell lymphoma patients who have relapsed or are refractory to previous chemotherapies including autologous transplantation.', 'detailedDescription': 'Conditioning therapy\n\n* Busulfan (Busulfex®; Patheon Manufacturing Services LLC, Greenville, NC 27834) 3.2 mg/kg + 5% DW (the diluent quantity should be 10 times the volume of Busulfan, so that the final concentration of busulfan becomes approximately 0.5 mg/mL), intravenously for 3 hours once daily for 3 days (days -7 to -5)\n* Fludarabine (Fludarabine®, Zydus Hospira Oncology Private Ltd., Ahmedabad, India) 30 mg/m2 + 5% DW 100㎖, intravenously for over 1 hour once daily for 6 days (days -8 to -3)\n\n * Busulfan should be infused as soon as completion of fludarabine infusion\n\nPrimary objective of this study I. To determine the 2-year progression-free survival of this reduced toxicity conditioning in relapsed or refractory T- and NK/T-cell non-hodgkin lymphoma patients.\n\nSecondary endpoints I. To evaluate the response rate, engraftment rate and time to engraftment, 2-year overall survival, 100-days treatment-related mortality, regimen-related toxicities by CTCAE version 4.03, post-transplantation complications (HVOD, acute/chronic graft-versus-host disease (GVHD), cytomegalovirus (CMV) infection,CMV disease) of this reduced toxicity conditioning in relapsed or refractory T- and NK/T-cell non-hodgkin lymphoma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 19 - 65\n2. Histologically confirmed T or NK cell lymphomas :\n\n * anaplastic large cell lymphoma\n * angioimmunoblastic T-cell lymphoma,\n * peripheral T-cell lymphoma, NOS\n * NK/T-cell lymphoma\n3. Relapsed after or refractory to one or more of previous chemotherapy including frontline autologous HSCT.\n4. At least one measured lesion using conventional CT or PET CT at the time of relapse after or refractory to one or more of previous chemotherapy and before salvage chemotherapy\n5. Complete or Partial response after short cycles of salvage chemotherapy\n6. Patients who have HLA full-match (8/8 in HLA-A, B, C, DR by DNA high-resolution technique) or one-locus mismatch (7/8) sibling, or unrelated bone marrow or peripheral blood or cord blood stem cell donors\n7. ECOG performance status ≤ 2\n8. Charlson Comorbidity Index (CCI) before HSCT ≤ 3\n9. Adequate renal function : serum creatinine level \\< 2.0 mg/dL\n10. Adequate liver function :\n\n * Transaminase (AST/ALT) \\< 3 X upper normal value (or \\< 5 x ULN in the presence of lymphoma involvement of the liver)\n * Total bilirubin \\< 2 X upper normal value (or \\< 5 x ULN in the presence of NK/T involvement of the liver)\n11. Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2D ECHO without clinically significant abnormality\n12. No clinically significant infection\n13. No clinically significant bleeding symptoms or sign\n14. Patients who decided to participate in this study and signed for a written consent\n\nExclusion Criteria:\n\n1. Adult T cell leukemia/lymphoma, Lymphoblastic lymphoma, Primary cutaneous CD30+ T cell disorders Mycosis fungoides, Sezary SD\n2. Patients who have previously performed Allo-HSCT\n3. T cell lymphoma with primary central nervous system (CNS) Involvement.\n\n \\*\\* However, patients who have only had prophylactic intrathecal or intravenous chemotherapy against CNS disease are eligible.\n4. Patients with a known history of HIV seropositivity or HCV (+).\n\n \\*\\* Patients with HBV are eligible. However, primary prophylaxis using antiviral agents is recommended for HBV carrier or prevent HBV reactivation during whole treatment period.\n5. Any other malignancies within the past 5 years\n\n \\*\\* Except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri\n6. Ejection fraction \\< 50% by a echocardiography\n7. FEV1 \\<60% or DLCO \\<60% by a pulmonary function test\n8. ECOG performance status 3 or 4\n9. Combined serious medical problem or disease\n\n * Serious or unstable heart disease although proper treatment\n * Myocardial infarction in recent 3 months\n * Underlying serious neurologic or psychiatric disease including dementia or seizure\n * Active uncontrolled infection including hepatitis B and C\n * Serious other medical problems observed by the doctors in charge of the patient\n10. Pregnant or lactating women, women of childbearing potential not employing adequate contraception'}, 'identificationModule': {'nctId': 'NCT02859402', 'acronym': 'RRTCLAlloSCT', 'briefTitle': 'Allogeneic Stem Cell Transplantation in Relapsed/Refractory T-, NK/T-cell Lymphomas', 'organization': {'class': 'OTHER', 'fullName': 'Keimyung University Dongsan Medical Center'}, 'officialTitle': 'Allogeneic Stem Cell Transplantation With 3-days Busulfan Plus Fludarabine as Conditioning in Patients With Relapsed or Refractory T-, NK/T-cell Lymphomas', 'orgStudyIdInfo': {'id': 'DSMC 2016-05-051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm', 'description': 'Conditioning chemotherapy: Fludarabine and Busulfan followed by Allogeneic stem cell transplantation', 'interventionNames': ['Drug: Busulfan', 'Drug: Fludarabine']}], 'interventions': [{'name': 'Busulfan', 'type': 'DRUG', 'otherNames': ['Busulfex'], 'description': 'intravenous, 3.2 mg/kg + 5% DW (the diluent quantity should be 10 times the volume of Busulfan, so that the final concentration of busulfan becomes approximately 0.5 mg/mL), once daily for 3 hours for 3 days (days -7 to -5)', 'armGroupLabels': ['Experimental Arm']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'intravenous, 30 mg/m2 + 5% DW 100㎖, over 1 hour once daily for 6 days (days -8 to -3)', 'armGroupLabels': ['Experimental Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '602-713', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ji Hyun Lee, MD., Ph.D.', 'role': 'CONTACT', 'email': 'hidrleejh@dau.ac.kr', 'phone': '+82-10-9397-5694'}], 'facility': 'Dong-A University', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '700-712', 'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young Rok Do, MD., Ph.D.', 'role': 'CONTACT', 'email': 'dyr1160@dsmc.or.kr', 'phone': '+82-10-3541-1160'}], 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'centralContacts': [{'name': 'Young Rok Do, MD., Ph.D.', 'role': 'CONTACT', 'email': 'dyr1160@dsmc.or.kr', 'phone': '+82-10-3541-1160'}, {'name': 'Ji Hyun Lee, MD., Ph.D.', 'role': 'CONTACT', 'email': 'hidrleejh@dau.ac.kr', 'phone': '+82-10-9397-5694'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'age,gender, disease type, stage, previous chemotherapy regimens, response to transplantation, patient survival, progression, toxicity profiles to the transpantation will be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Young Rok Do', 'investigatorAffiliation': 'Keimyung University Dongsan Medical Center'}}}}