Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027547
Status:
COMPLETED
Last Update Posted:
2011-11-30
First Post:
2001-12-07
Brief Title:
Combination Chemotherapy and Total-Body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Acute Lymphoblastic Leukemia
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Nonmyeloablative Allogeneic Hematopoietic Cell Transplantation From HLA Matched Sibling Donors For Treatment Of Patients With High Risk Acute Lymphocytic Leukemia In Complete Remission
Status:
COMPLETED
Status Verified Date:
2011-11
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 Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy Sometimes the transplanted cells are rejected by the bodys normal tissues Mycophenolate mofetil and donor white blood cells may prevent this from happening
PURPOSE Phase III trial to determine the effectiveness of combination chemotherapy and total-body irradiation followed by peripheral stem cell transplantation in treating patients who have acute lymphoblastic leukemia
PURPOSE Phase III trial to determine the effectiveness of combination chemotherapy and total-body irradiation followed by peripheral stem cell transplantation in treating patients who have acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES
Determine if a one-year disease free survival of 40 and a day 200 transplant-related mortality of less than 25 can be achieved in patients with high-risk acute lymphoblastic leukemia in complete remission treated with a nonmyeloablative conditioning regimen comprising fludarabine and total body irradiation followed by allogeneic peripheral blood stem cell or bone marrow transplantation
Evaluate the efficacy and toxicity of donor lymphocyte infusion in the treatment of minimal residual disease after nonmyeloablative allografting in these patients
OUTLINE This is a multicenter study
Patients receive a nonmyeloablative conditioning regimen comprising fludarabine IV on days -4 to -2 and total body irradiation TBI on day 0 Children undergo allogeneic peripheral blood stem cell transplantation PBSCT or bone marrow transplantation after TBI on day 0 Adults undergo filgrastim G-CSF-mobilized allogeneic PBSCT after TBI on day 0
Patients also receive graft-versus-host disease GVHD prophylaxis therapy comprising oral cyclosporine twice daily on days -3 to 56 and then tapered and oral mycophenolate mofetil once at 5-10 hours after transplantation on day 0 and then twice daily on days 1-27
Patients who have no evidence of grade 2 or greater acute GVHD or clinically extensive chronic GVHD have been off GVHD prophylaxis therapy for 1-2 weeks and have stable or increasing minimal residual disease after discontinuation of GVHD prophylaxis therapy receive donor lymphocyte infusion DLI IV over 30 minutes DLI repeats every 4 weeks for a total of 3 doses if necessary
Patients without a history of CNS leukemia and patients with a history of CNS leukemia previously treated with prophylactic craniospinal irradiation receive methotrexate MTX or cytarabine ARA-C intrathecally IT for a total of 2 doses before transplantation and for a total of 6 doses beginning on day 32 after transplantation Patients with a history of CNS leukemia not previously treated with craniospinal irradiation undergo craniospinal irradiation for 11 days before conditioning regimen and then MTX or ARA-C IT for a total of 6 doses beginning on day 32 after transplantation Male patients also undergo testicular radiotherapy for 7 days
Patients are followed at 1 2 3 6 12 18 and 24 months
PROJECTED ACCRUAL A total of 30 patients 20 adults and 10 children will be accrued for this study within 2 years
Determine if a one-year disease free survival of 40 and a day 200 transplant-related mortality of less than 25 can be achieved in patients with high-risk acute lymphoblastic leukemia in complete remission treated with a nonmyeloablative conditioning regimen comprising fludarabine and total body irradiation followed by allogeneic peripheral blood stem cell or bone marrow transplantation
Evaluate the efficacy and toxicity of donor lymphocyte infusion in the treatment of minimal residual disease after nonmyeloablative allografting in these patients
OUTLINE This is a multicenter study
Patients receive a nonmyeloablative conditioning regimen comprising fludarabine IV on days -4 to -2 and total body irradiation TBI on day 0 Children undergo allogeneic peripheral blood stem cell transplantation PBSCT or bone marrow transplantation after TBI on day 0 Adults undergo filgrastim G-CSF-mobilized allogeneic PBSCT after TBI on day 0
Patients also receive graft-versus-host disease GVHD prophylaxis therapy comprising oral cyclosporine twice daily on days -3 to 56 and then tapered and oral mycophenolate mofetil once at 5-10 hours after transplantation on day 0 and then twice daily on days 1-27
Patients who have no evidence of grade 2 or greater acute GVHD or clinically extensive chronic GVHD have been off GVHD prophylaxis therapy for 1-2 weeks and have stable or increasing minimal residual disease after discontinuation of GVHD prophylaxis therapy receive donor lymphocyte infusion DLI IV over 30 minutes DLI repeats every 4 weeks for a total of 3 doses if necessary
Patients without a history of CNS leukemia and patients with a history of CNS leukemia previously treated with prophylactic craniospinal irradiation receive methotrexate MTX or cytarabine ARA-C intrathecally IT for a total of 2 doses before transplantation and for a total of 6 doses beginning on day 32 after transplantation Patients with a history of CNS leukemia not previously treated with craniospinal irradiation undergo craniospinal irradiation for 11 days before conditioning regimen and then MTX or ARA-C IT for a total of 6 doses beginning on day 32 after transplantation Male patients also undergo testicular radiotherapy for 7 days
Patients are followed at 1 2 3 6 12 18 and 24 months
PROJECTED ACCRUAL A total of 30 patients 20 adults and 10 children will be accrued for this study within 2 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 |
|---|---|---|---|
| FHCRC-158600 | None | None | None |
| NCI-H01-0080 | None | None | None |
| CDR0000069042 | REGISTRY | PDQ | None |