Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002534
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A RANDOMIZED TRIAL OF UNMODIFIED VERSUS T-CELL DEPLETED ALLOGENEIC HLA-IDENTICAL BONE MARROW TRANSPLANTATION FOR THE TREATMENT OF ACUTE LEUKEMIAS
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Randomized phase III trial to compare the effectiveness of bone marrow transplantation using untreated or treated bone marrow in treating patients with acute leukemia in first or second remission
PURPOSE Randomized phase III trial to compare the effectiveness of bone marrow transplantation using untreated or treated bone marrow in treating patients with acute leukemia in first or second remission
Detailed Description:
OBJECTIVES I Compare the efficacy of T-cell-depleted vs unmodified allogeneic marrow rescue with regard to disease-free survival post-transplantation leukemic relapse rate incidence and severity of graft-versus-host disease quality of engraftment and hematopoietic reconstitution and immunoreconstitution following transplantation in patients with acute leukemia in first or second remission
OUTLINE This is a randomized study Patients are stratified according to disease acute lymphocytic leukemia ALL vs acute myeloid leukemia AML and age 20 and under vs over 20 Patients are randomized to one of two treatment arms Patients under age 5 are nonrandomly assigned to Arm I and those over age 55 are nonrandomly assigned to Arm II Arm I Patients receive total body radiotherapy on days -7 through -4 followed by cyclophosphamide IV on days -3 and -2 Patients undergo allogeneic bone marrow transplantation ABMT IV over 2-4 hours on day 0 Patients also receive standard graft vs host disease prophylaxis with cyclosporine and methotrexate Arm II Patients receive total body radiotherapy on days -9 through -6 thiotepa IV on days -5 and -4 and cyclophosphamide as in Arm I Patients undergo T-cell depleted ABMT IV over 15 minutes on day 0 Patients over age 15 receiving bone marrow from female donors over age 30 or from male donors of any age also receive graft rejection prophylaxis consisting of antithymocyte globulin IV over 6-8 hours on days -5 and -4 and oral methylprednisolone twice daily on days -5 and -4 Beginning 2 months following transplantation adult patients with AML and a prior history of CNS disease all adult patients with ALL and all pediatric patients ALL and ANLL receive CNS leukemia prophylaxis with cytarabine intrathecally with the diagnostic lumbar puncture and then monthly for 5 months 1 year in patients with a prior history of CNS leukemia
PROJECTED ACCRUAL A total of 128 patients will be randomized At an anticipated accrual rate of 35 patientsyear accrual is expected to be completed in 4 years
OUTLINE This is a randomized study Patients are stratified according to disease acute lymphocytic leukemia ALL vs acute myeloid leukemia AML and age 20 and under vs over 20 Patients are randomized to one of two treatment arms Patients under age 5 are nonrandomly assigned to Arm I and those over age 55 are nonrandomly assigned to Arm II Arm I Patients receive total body radiotherapy on days -7 through -4 followed by cyclophosphamide IV on days -3 and -2 Patients undergo allogeneic bone marrow transplantation ABMT IV over 2-4 hours on day 0 Patients also receive standard graft vs host disease prophylaxis with cyclosporine and methotrexate Arm II Patients receive total body radiotherapy on days -9 through -6 thiotepa IV on days -5 and -4 and cyclophosphamide as in Arm I Patients undergo T-cell depleted ABMT IV over 15 minutes on day 0 Patients over age 15 receiving bone marrow from female donors over age 30 or from male donors of any age also receive graft rejection prophylaxis consisting of antithymocyte globulin IV over 6-8 hours on days -5 and -4 and oral methylprednisolone twice daily on days -5 and -4 Beginning 2 months following transplantation adult patients with AML and a prior history of CNS disease all adult patients with ALL and all pediatric patients ALL and ANLL receive CNS leukemia prophylaxis with cytarabine intrathecally with the diagnostic lumbar puncture and then monthly for 5 months 1 year in patients with a prior history of CNS leukemia
PROJECTED ACCRUAL A total of 128 patients will be randomized At an anticipated accrual rate of 35 patientsyear accrual is expected to be completed in 4 years
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 |
|---|---|---|---|
| NCI-H93-0293 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000078464 | REGISTRY | None | None |