Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002789
Status:
COMPLETED
Last Update Posted:
2010-03-30
First Post:
1999-11-01
Brief Title:
Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myeloid Leukemia
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A PHASE III RANDOMIZED STUDY COMPARING G-CSF MOBILIZED PERIPHERAL BLOOD STEM CELLS WITH MARROW AS THE SOURCE OF STEM CELLS FOR ALLOGENEIC TRANSPLANTS FROM HLA IDENTICAL RELATED DONORS FOR THE TREATMENT OF CHRONIC MYELOID LEUKEMIA
Status:
COMPLETED
Status Verified Date:
2010-03
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 or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells Sometimes the transplanted cells can make an immune response against the bodys normal tissues Stem cells that have been treated in the laboratory with filgrastim may prevent this from happening Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells It is not yet known which treatment is more effective for chronic myeloid leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of donor peripheral stem cell transplantation with donor bone marrow transplantation in treating patients with chronic myeloid leukemia
PURPOSE Randomized phase III trial to compare the effectiveness of donor peripheral stem cell transplantation with donor bone marrow transplantation in treating patients with chronic myeloid leukemia
Detailed Description:
OBJECTIVES I Compare the incidence of persistent cytogenetic or hematologic relapse in patients with chronic myeloid leukemia in chronic or accelerated phase treated with transplantation using filgrastim G-CSF-mobilized peripheral blood stem cells vs bone marrow from HLA-identical related donors II Compare survival and nonrelapse mortality in patients treated with these regimens III Compare incidence and severity of acute and chronic graft versus host disease in patients treated with these regimens IV Compare hospitalization and treatment associated expenses for patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to age 15-39 vs 40-65 interval from diagnosis to transplantation under 2 years vs 2 years or more and permutations of patient and donor gender Patients are randomized to one of two treatment arms Arm I Patients receive a preparative regimen comprising busulfan orally or IV 4 times daily on days -7 to -4 and cyclophosphamide IV on days -3 and -2 Allogeneic filgrastim G-CSF-mobilized peripheral blood stem cells are infused on day 0 Arm II Busulfan and cyclophosphamide are administered as in arm I Allogeneic bone marrow is infused on day 0 Patients receive graft-versus-host disease prophylaxis comprising methotrexate IV on days 1 3 6 and 11 and cyclosporine IV over 1-4 hours or orally every 12 hours on days -1 to 80 and then tapered Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 3 years
OUTLINE This is a randomized multicenter study Patients are stratified according to age 15-39 vs 40-65 interval from diagnosis to transplantation under 2 years vs 2 years or more and permutations of patient and donor gender Patients are randomized to one of two treatment arms Arm I Patients receive a preparative regimen comprising busulfan orally or IV 4 times daily on days -7 to -4 and cyclophosphamide IV on days -3 and -2 Allogeneic filgrastim G-CSF-mobilized peripheral blood stem cells are infused on day 0 Arm II Busulfan and cyclophosphamide are administered as in arm I Allogeneic bone marrow is infused on day 0 Patients receive graft-versus-host disease prophylaxis comprising methotrexate IV on days 1 3 6 and 11 and cyclosporine IV over 1-4 hours or orally every 12 hours on days -1 to 80 and then tapered Patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| CDR0000064853 | REGISTRY | PDQ | None |
| FHCRC-109200 | None | None | None |
| NCI-H96-0926 | None | None | None |