Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244829
Status:
COMPLETED
Last Update Posted:
2011-11-30
First Post:
2005-10-25
Brief Title:
Imatinib Mesylate After a Donor Stem Cell Transplant in Treating Patients With Philadelphia Chromosome-Positive Leukemia
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Multicenter Pilot Study Evaluating the Safety and Efficacy of Imatinib as Post-Transplant Therapy for High- Risk Philadelphia Chromosome-Positive Leukemias
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 Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Giving imatinib mesylate after a donor stem cell transplant may prevent the recurrence of Philadelphia chromosome-positive leukemia
PURPOSE This phase III trial is studying the side effects of giving imatinib mesylate after a donor stem cell transplant and to see how well it works in treating patients with Philadelphia chromosome-positive leukemia
PURPOSE This phase III trial is studying the side effects of giving imatinib mesylate after a donor stem cell transplant and to see how well it works in treating patients with Philadelphia chromosome-positive leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the safety of adjuvant imatinib mesylate after allogeneic hematopoietic stem cell transplantation AHSCT in patients with high-risk Philadelphia chromosome-positive leukemia
Secondary
Determine the bcrabl transcript load during the first 90 days after AHSCT in patients treated with this drug from the time of engraftment
Determine the 1-year survival of patients treated with this drug
OUTLINE This is an open-label pilot multicenter study
Beginning within 14-30 days after allogeneic stem cell transplantation patients receive oral imatinib mesylate once daily until 1 year after transplantation Treatment continues in the absence of unacceptable toxicity or disease progression
Patients are followed for survival
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Primary
Determine the safety of adjuvant imatinib mesylate after allogeneic hematopoietic stem cell transplantation AHSCT in patients with high-risk Philadelphia chromosome-positive leukemia
Secondary
Determine the bcrabl transcript load during the first 90 days after AHSCT in patients treated with this drug from the time of engraftment
Determine the 1-year survival of patients treated with this drug
OUTLINE This is an open-label pilot multicenter study
Beginning within 14-30 days after allogeneic stem cell transplantation patients receive oral imatinib mesylate once daily until 1 year after transplantation Treatment continues in the absence of unacceptable toxicity or disease progression
Patients are followed for survival
PROJECTED ACCRUAL A total of 20 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 |
|---|---|---|---|
| CDR0000355118 | REGISTRY | PDQ | None |
| FHCRC-186700 | None | None | None |