Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301912
Status:
WITHDRAWN
Last Update Posted:
2012-10-02
First Post:
2006-03-09
Brief Title:
Busulfan and Fludarabine Before Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation
Status:
WITHDRAWN
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn because study never opened to accrual
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 such as busulfan and fludarabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving chemotherapy with a peripheral stem cell or bone marrow transplant may allow more chemotherapy to be given so that more cancer cells are killed Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Tacrolimus and methotrexate may stop this from happening
PURPOSE This phase II trial is studying how well giving busulfan together with fludarabine before donor stem cell transplant works in treating patients with hematologic cancer
PURPOSE This phase II trial is studying how well giving busulfan together with fludarabine before donor stem cell transplant works in treating patients with hematologic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety in terms of treatment-related mortality at 100 days post-transplantation of a myeloablative preparative regimen comprising busulfan and fludarabine and graft-vs-host disease GVHD prophylaxis comprising tacrolimus and methotrexate in patients with hematopoietic disorders undergoing matched unrelated donor stem cell transplantation
Determine the efficacy in terms of overall survival at 1-year post-transplantation in patients treated with this regimen
Secondary
Determine organ toxicity in patients treated with this regimen
Determine neutrophil and platelet recovery in patients treated with this regimen
Determine the incidence and severity of acute and chronic GVHD in patients treated with this regimen
OUTLINE
Myeloablative preparative regimen Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and fludarabine IV over 30 minutes on days -7 to -3
Allogeneic stem cell transplantation Patients undergo allogeneic peripheral blood stem cell or bone marrow transplantation on day 0 Patients also receive filgrastim G-CSF subcutaneously daily beginning on day 7 and continuing until blood counts recover
Graft-vs-host disease prophylaxis Patients receive tacrolimus IV continuously beginning on day -2 and continuing until discharged from the hospital may convert to oral dosing administered twice daily when tolerated and methotrexate IV over 15-30 minutes on days 1 3 6 and 11
After completion of study therapy patients are followed periodically
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
Primary
Determine the safety in terms of treatment-related mortality at 100 days post-transplantation of a myeloablative preparative regimen comprising busulfan and fludarabine and graft-vs-host disease GVHD prophylaxis comprising tacrolimus and methotrexate in patients with hematopoietic disorders undergoing matched unrelated donor stem cell transplantation
Determine the efficacy in terms of overall survival at 1-year post-transplantation in patients treated with this regimen
Secondary
Determine organ toxicity in patients treated with this regimen
Determine neutrophil and platelet recovery in patients treated with this regimen
Determine the incidence and severity of acute and chronic GVHD in patients treated with this regimen
OUTLINE
Myeloablative preparative regimen Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and fludarabine IV over 30 minutes on days -7 to -3
Allogeneic stem cell transplantation Patients undergo allogeneic peripheral blood stem cell or bone marrow transplantation on day 0 Patients also receive filgrastim G-CSF subcutaneously daily beginning on day 7 and continuing until blood counts recover
Graft-vs-host disease prophylaxis Patients receive tacrolimus IV continuously beginning on day -2 and continuing until discharged from the hospital may convert to oral dosing administered twice daily when tolerated and methotrexate IV over 15-30 minutes on days 1 3 6 and 11
After completion of study therapy patients are followed periodically
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCSF-02257 | None | None | None |
| UCSF-2214 | None | None | None |
| UCSF-H24045-22163-04 | None | None | None |