Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002832
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
1999-11-01
Brief Title:
Decitabine and Peripheral Stem Cell Transplantation in Treating Patients Who Have Relapsed Following Bone Marrow Transplantation for Leukemia Myelodysplastic Syndrome or Chronic Myelogenous Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Trial of Decitabine and Allogeneic Peripheral Blood Stem Cells Transplantation for Treatment of Relapse Post Allogeneic Bone Marrow Transplantation
Status:
COMPLETED
Status Verified Date:
2012-07
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 Peripheral stem cell transplantation may be an effective treatment for leukemia myelodysplastic syndrome or chronic myelogenous leukemia that has relapsed following bone marrow transplantation
PURPOSE Phase III trial to study the effectiveness of decitabine and peripheral stem cell transplantation in treating patients who have leukemia myelodysplastic syndrome or chronic myelogenous leukemia that has relapsed after bone marrow transplantation
PURPOSE Phase III trial to study the effectiveness of decitabine and peripheral stem cell transplantation in treating patients who have leukemia myelodysplastic syndrome or chronic myelogenous leukemia that has relapsed after bone marrow transplantation
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of decitabine in patients with relapse post allogenic bone marrow transplant II Determine the toxicity of decitabine combined with filgrastim G-CSF primed allogeneic peripheral blood stem cells in patients who relapsed within 1 year after allogeneic bone marrow transplantation III Determine the effectiveness in reinducing remission in these patients
OUTLINE Patients receive decitabine IV for 6 hours every 12 hr for 5 days Peripheral blood stem cells PBSC are administered 5 days after last dose of decitabine Donors receive filgrastim subcutaneously SQ daily every 12 hours starting 2-4 days prior to first PBSC collection If insufficient number of cells are collected bone marrow can be harvested for supplementation Donor cells should be collected prior to decitabine infusion Patients receive filgrastim SQ administered daily starting 1 day after PBSC infusion until blood counts recover For GVHD prophylaxis patients receive cyclosporine IV daily on day -2 then orally once dose is tolerable Dose of decitabine is escalated in cohorts of 3-6 patients If dose limiting toxicity occurs in 2 of 6 patients at a given dose level then that dose is declared the maximum tolerated dose Patients are followed weekly If none of the first 5 patients survive in remission for more than 100 days the study will be terminated
PROJECTED ACCRUAL At least 15 patients will be accrued for this study over 2 years
OUTLINE Patients receive decitabine IV for 6 hours every 12 hr for 5 days Peripheral blood stem cells PBSC are administered 5 days after last dose of decitabine Donors receive filgrastim subcutaneously SQ daily every 12 hours starting 2-4 days prior to first PBSC collection If insufficient number of cells are collected bone marrow can be harvested for supplementation Donor cells should be collected prior to decitabine infusion Patients receive filgrastim SQ administered daily starting 1 day after PBSC infusion until blood counts recover For GVHD prophylaxis patients receive cyclosporine IV daily on day -2 then orally once dose is tolerable Dose of decitabine is escalated in cohorts of 3-6 patients If dose limiting toxicity occurs in 2 of 6 patients at a given dose level then that dose is declared the maximum tolerated dose Patients are followed weekly If none of the first 5 patients survive in remission for more than 100 days the study will be terminated
PROJECTED ACCRUAL At least 15 patients will be accrued for this study over 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 |
|---|---|---|---|
| CDR0000065034 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-DM-94077 | OTHER | None | None |
| NCI-G96-1000 | None | None | None |