Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006451
Status:
WITHDRAWN
Last Update Posted:
2020-01-03
First Post:
2000-11-06
Brief Title:
Bone Marrow Transplantation in Treating Patients With Leukemia
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
T-cell Depletion In Unrelated Donor Marrow Transplantation
Status:
WITHDRAWN
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to no accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells
PURPOSE Randomized phase IIIII trial to determine the effectiveness of bone marrow transplantation in treating patients who have leukemia
PURPOSE Randomized phase IIIII trial to determine the effectiveness of bone marrow transplantation in treating patients who have leukemia
Detailed Description:
OBJECTIVES I Compare unrelated donor bone marrow transplantation using T-cell-depleted marrow versus unmodified marrow in adults and children with leukemia II Evaluate 2-year leukemia-free survival primary and secondary graft failure graft-versus-host disease infection and relapse in these patients III Assess the quality of life associated with T-cell-depleted versus unmodified unrelated donor transplantation
OUTLINE This is a randomized multicenter study Patients are stratified by center Patients receive myeloablative therapy according to diagnosis those with acute lymphocytic leukemia and lymphoblastic lymphoma are treated with total body irradiation TBI with a testicular and chest wall boost as appropriate followed by cyclophosphamide CTX patients with undifferentiated or biphenotypic leukemia or with acute or chronic myelocytic leukemia are treated with CTX followed by TBI Patients are then randomly assigned to receive non-T-cell-depleted unrelated marrow versus T-cell-depleted unrelated marrow The modified marrow is depleted of T-lymphocytes by counterflow elutriation and positively selected for CD34 cells Graft-versus-host disease GVHD prophylaxis with cyclosporine and methotrexate is given to the unmodified marrow group Patients who receive modified marrow are given antithymocyte globulin or methylprednisolone for graft rejection prophylaxis before transplantation and cyclosporine and methylprednisolone for GVHD prophylaxis after transplantation
OUTLINE This is a randomized multicenter study Patients are stratified by center Patients receive myeloablative therapy according to diagnosis those with acute lymphocytic leukemia and lymphoblastic lymphoma are treated with total body irradiation TBI with a testicular and chest wall boost as appropriate followed by cyclophosphamide CTX patients with undifferentiated or biphenotypic leukemia or with acute or chronic myelocytic leukemia are treated with CTX followed by TBI Patients are then randomly assigned to receive non-T-cell-depleted unrelated marrow versus T-cell-depleted unrelated marrow The modified marrow is depleted of T-lymphocytes by counterflow elutriation and positively selected for CD34 cells Graft-versus-host disease GVHD prophylaxis with cyclosporine and methotrexate is given to the unmodified marrow group Patients who receive modified marrow are given antithymocyte globulin or methylprednisolone for graft rejection prophylaxis before transplantation and cyclosporine and methylprednisolone for GVHD prophylaxis after transplantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMN-MT-9506 | OTHER | Blood and Marrow Transplantation Program | None |