Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045422
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2002-09-06
Brief Title:
Interferon Alfa and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase II Open Label Study to Determine Safety and Efficacy of Interferon-alpha in Combination With Imantinib Mesylate Gleevec in Patients With Chronic Phase Chronic Myelogenous Leukemia Who Have Not Achieved a Complete Cytogenetic Response to Gleevec as a Single Agent
Status:
COMPLETED
Status Verified Date:
2013-06
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 Interferon alfa may interfere with the growth of cancer cells Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth Combining interferon alfa with imatinib mesylate may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining interferon alfa with imatinib mesylate in treating patients who have chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of combining interferon alfa with imatinib mesylate in treating patients who have chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Determine whether interferon alfa in combination with imatinib mesylate adds to the hematologic cytogenetic and molecular response rates in patients with chronic phase chronic myelogenous leukemia that is newly diagnosed or has not achieved a complete cytogenetic response to imatinib mesylate alone
OUTLINE Patients receive oral imatinib mesylate STI-571 once daily for 9 months At 9 months patients with more than 35 Philadelphia chromosome-positive Ph cells in bone marrow receive oral STI-571 twice daily for 3 more months At 12 months patients with more than 35 Ph cells in bone marrow receive oral STI-571 once daily and interferon alfa subcutaneously once daily Treatment continues for at least 1 year in the absence of disease progression or unacceptable toxicity Patients with an appropriate HLA-matched donor may choose to have a bone marrow transplantation at any time during the study
Patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 80 patients 60 without an HLA-matched donor and 20 with an HLA-matched donor will be accrued for this study within 5 years
Determine whether interferon alfa in combination with imatinib mesylate adds to the hematologic cytogenetic and molecular response rates in patients with chronic phase chronic myelogenous leukemia that is newly diagnosed or has not achieved a complete cytogenetic response to imatinib mesylate alone
OUTLINE Patients receive oral imatinib mesylate STI-571 once daily for 9 months At 9 months patients with more than 35 Philadelphia chromosome-positive Ph cells in bone marrow receive oral STI-571 twice daily for 3 more months At 12 months patients with more than 35 Ph cells in bone marrow receive oral STI-571 once daily and interferon alfa subcutaneously once daily Treatment continues for at least 1 year in the absence of disease progression or unacceptable toxicity Patients with an appropriate HLA-matched donor may choose to have a bone marrow transplantation at any time during the study
Patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 80 patients 60 without an HLA-matched donor and 20 with an HLA-matched donor will be accrued for this study within 5 years
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 |
|---|---|---|---|
| NCI-G02-2105 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000256469 | REGISTRY | None | None |