Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-03-03 @ 6:15 AM
Study NCT ID:
NCT00038818
Status:
TERMINATED
Last Update Posted:
2012-08-23
First Post:
2002-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Low accrual.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2002-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-22', 'studyFirstSubmitDate': '2002-06-05', 'studyFirstSubmitQcDate': '2002-06-06', 'lastUpdatePostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Response Rates of Acute or Chronic GVHD', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CML', 'MM', 'NHL', 'HD', 'CLL', 'CD8 Depleted', 'Donor Lymphocyte'], 'conditions': ['Chronic Myelogenous Leukemia', 'Multiple Myeloma', "Non Hodgkin's Lymphoma", "Hodgkin's Disease", 'Chronic Lymphocytic Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'UT MD Anderson Cancer Center website'}]}, 'descriptionModule': {'briefSummary': "Primary Objectives:\n\nTo evaluate response rates of acute or chronic Graft-versus-host disease (GVHD) following CD8 depleted DLI (Depleted Donor Lymphocyte Infusions) in patients with Chronic myelomonocytic leukemia (CMML), chronic lymphoid leukemia (CLL), Non-Hodgkin's lymphoma (NLM), Multiple Myeloma (MM) and Hodgkin's Lymphoma (HD).\n\nSecondary Objectives:\n\n* To evaluate safety and treatment related mortality after CD8 depleted DLI.\n* To evaluate the time to onset of GVHD following DLI and response to GVHD treatment.\n* To evaluate the incidence and timing of pancytopenia following DLI.\n* To evaluate disease-free survival, overall survival and relapse rates in three cohorts of patients; early relapse CML, late relapse CML and lymphoproliferative disorders (HD, CLL, NHL and MM).\n* To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte infusions.\n* To evaluate the number of apheresis procedures needed to collect appropriate doses of CD4+ cells."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "* Patients of any age who have previously undergone allogeneic hematopoietic transplantation and have evidence of donor cell engraftment (\\>20% donor cell within three months of study entry)\n* Expected survival \\>4 weeks\n* CML patients with molecular, cytogenetic or hematologic relapse following allogeneic transplantation\n\n 1. Molecular relapse- patients are eligible if bcr/abl is detectable at any time after day 180 post-allogeneic transplantation or if a negative bcr/abl PCR test was documented post-transplantation and the bcr/abl test is now positive by consecutive PCR determinations at least 4 weeks apart.\n 2. Cytogenetic relapse-patients are eligible if standard cytogenetics demonstrate \\>10% t (9,22) positive cells greater than 60 days after myeloablative transplantation or 10% t (9,22) positive cells greater than 100 days after nonmyeloablative transplantation.\n* CML patients with accelerated phase or blast crisis following allogeneic transplantation\n* Patients with CLL, NHL, MM, or HD who have evidence of disease relapse or persistent disease at 60 days post-allo BMT and/or:\n\n 1. MM- patients with a rising M-protein is detectable at 180 days post-transplant\n 2. NHL - patients with molecular evidence of disease (bcl-2, t (4,11), etc.) at 180 days post transplant\n 3. CLL, NHL or HD - patients with clear cut evidence of tumor growth at any time post-transplant are eligible\n* Patients undergoing an HLA -identical or 5/6 antigen match transplant from a related or unrelated donor\n* Patient's original donor must be available for lymphocyte donation\n* There must be no evidence of active acute or graft-versus-host disease and patients should be off all immunosuppressive agents for, at least, two weeks prior to DLI. Patients on stable dose of methylprednisolone (\\<16 mg/d) without evidence of active GVHD are also eligible.\n* Patients must have a Zubrod PS\\<2 (see appendix 7), Cr\\<2.5, bilirubin \\<3, and transaminases (SGPT, SGOT) \\<4x normal\n* Patient must be able to sign informed consent"}, 'identificationModule': {'nctId': 'NCT00038818', 'briefTitle': 'CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'ID00-335'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD8 DLI', 'description': 'CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)', 'interventionNames': ['Biological: CD8 Depleted Donor Lymphocyte']}], 'interventions': [{'name': 'CD8 Depleted Donor Lymphocyte', 'type': 'BIOLOGICAL', 'armGroupLabels': ['CD8 DLI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UT MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Richard Champlin, MD, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT MD Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eligix', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}