Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305708
Status:
COMPLETED
Last Update Posted:
2012-11-12
First Post:
2006-03-21
Brief Title:
Busulfan Antithymocyte Globulin and Fludarabine Followed By a Donor Stem Cell Transplant in Treating Young Patients With Blood Disorders Bone Marrow Disorders Chronic Myelogenous Leukemia in First Chronic Phase or Acute Myeloid Leukemia in First Remission
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Bone Marrow Stem Cell Transplantation for Children With Stem Cell Defects Marrow Failure Syndromes or Myeloid Leukemia in 1Remission
Status:
COMPLETED
Status Verified Date:
2012-11
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 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 more than one drug combination chemotherapy may kill more cancer cells A donor peripheral blood bone marrow or umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Giving antithymocyte globulin before the transplant may stop this from happening
PURPOSE This phase III trial is studying the side effects of busulfan antithymocyte globulin and fludarabine when given together with a donor stem cell transplant in treating young patients with blood disorders bone marrow disorders chronic myelogenous leukemia in first chronic phase or acute myeloid leukemia in first remission
PURPOSE This phase III trial is studying the side effects of busulfan antithymocyte globulin and fludarabine when given together with a donor stem cell transplant in treating young patients with blood disorders bone marrow disorders chronic myelogenous leukemia in first chronic phase or acute myeloid leukemia in first remission
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy in terms of graft rejection at 4 weeks of a conditioning regimen comprising busulfan anti-thymocyte globulin and fludarabine followed by donor stem cell transplantation SCT in children with stem cell defects marrow failure syndromes chronic myelogenous leukemia in first chronic phase or acute myeloid leukemia in first remission
Determine the pharmacokinetics of busulfan in children undergoing donor SCT
Secondary
Determine the toxicity of this regimen in these patients
Determine engraftment at 3 6 9 and 12 months and mixed chimerism in patients treated with this regimen
Determine overall and disease-free survival of patients treated with this regimen
OUTLINE Patients receive one of the following cytoreductive regimens
Regimen 1 patients with an HLA genotypic matched sibling donor Patients receive busulfan IV over 2 hours every 6 hours on days -9 to -6 fludarabine IV on days -5 to -2 and anti-thymocyte globulin ATG IV over 10 hours on days -3 to -1
Regimen 2 patients with an HLA closely matched related not genotypic or unrelated donor Patients receive busulfan and fludarabine as in regimen 1 and ATG IV over 10 hours on days -4 to -1
Regimen 3 patients with Fanconis anemia or severe aplastic anemia with genotypic matched sibling donor Patients receive fludarabine as in regimen 1 and ATG as in regimen 2
Regimen 4 patients with Fanconis anemia who have a closely matched related not genotypic or unrelated donor Patients undergo thoracoabdominal irradiation on day -6 and receive fludarabine as in regimen 1 and ATG as in regimen 2
All patients undergo allogeneic bone marrow umbilical cord blood or peripheral blood stem cell transplantation on day 0
After the completion of study treatment patients are followed periodically for 20 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Primary
Determine the efficacy in terms of graft rejection at 4 weeks of a conditioning regimen comprising busulfan anti-thymocyte globulin and fludarabine followed by donor stem cell transplantation SCT in children with stem cell defects marrow failure syndromes chronic myelogenous leukemia in first chronic phase or acute myeloid leukemia in first remission
Determine the pharmacokinetics of busulfan in children undergoing donor SCT
Secondary
Determine the toxicity of this regimen in these patients
Determine engraftment at 3 6 9 and 12 months and mixed chimerism in patients treated with this regimen
Determine overall and disease-free survival of patients treated with this regimen
OUTLINE Patients receive one of the following cytoreductive regimens
Regimen 1 patients with an HLA genotypic matched sibling donor Patients receive busulfan IV over 2 hours every 6 hours on days -9 to -6 fludarabine IV on days -5 to -2 and anti-thymocyte globulin ATG IV over 10 hours on days -3 to -1
Regimen 2 patients with an HLA closely matched related not genotypic or unrelated donor Patients receive busulfan and fludarabine as in regimen 1 and ATG IV over 10 hours on days -4 to -1
Regimen 3 patients with Fanconis anemia or severe aplastic anemia with genotypic matched sibling donor Patients receive fludarabine as in regimen 1 and ATG as in regimen 2
Regimen 4 patients with Fanconis anemia who have a closely matched related not genotypic or unrelated donor Patients undergo thoracoabdominal irradiation on day -6 and receive fludarabine as in regimen 1 and ATG as in regimen 2
All patients undergo allogeneic bone marrow umbilical cord blood or peripheral blood stem cell transplantation on day 0
After the completion of study treatment patients are followed periodically for 20 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
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 |
|---|---|---|---|
| UCSF-H411-17802-06 | None | None | None |
| UCSF-01152 | None | None | None |