Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of chronic phase chronic myelogenous leukemia - Cytogenetically confirmed Philadelphia chromosome-positive disease or other variant of t(9;22) - No secondary chromosomal abnormalities - No more than 10% blasts in bone marrow - Newly diagnosed OR - Received prior imatinib mesylate as a single agent for no more than the past 9 months without achieving a complete cytogenetic response - No evidence of extramedullary involvement except nodes, liver, or spleen PATIENT CHARACTERISTICS: Age - Any age Performance status - ECOG 0-3 Life expectancy - Not specified Hematopoietic - Platelet count greater than 100,000/mm^3 - Absolute neutrophil count greater than 1,500/mm^3 Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - SGOT no greater than 2 times ULN - INR no greater than 1.5 times ULN* - PTT no greater than 1.5 times ULN* NOTE: * Except patients on anticoagulants Renal - Creatinine no greater than 2 times ULN Other - Considered potentially reliable - No history of noncompliance to medical regimens - No other active malignancy requiring chemotherapy or radiotherapy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier-method contraception during and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy - No prior interferon therapy - No prior stem cell or bone marrow transplantation Chemotherapy - No prior chemotherapy (except hydroxyurea and/or anagrelide to control counts) Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - At least 4 weeks since prior major surgery and recovered Other - No concurrent grapefruit juice or grapefruit products - No concurrent warfarin - Concurrent low-molecular weight heparin allowed


Study is Available At:


Original ID:

02-013


NCT ID:

NCT00045422


Secondary ID:

CDR0000256469


Study Acronym:


Brief Title:

Interferon Alfa and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan-Kettering Cancer Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Open Label, Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Ellin Berman, MD
Study Chair
Memorial Sloan-Kettering Cancer Center

Study Dates

Start Date:April 2002
Completion Date:October 2003
Completion Type:Actual
Primary Completion Date:October 2003
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 4, 2013
First Received Date:September 6, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:recombinant interferon alfa
Intervention Type:Drug
Name:imatinib mesylate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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