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

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon alfa
imatinib mesylate
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring chronic myelogenous leukemia, BCR-ABL1 positive, chronic phase chronic myelogenous leukemia, childhood chronic myelogenous leukemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 6, 2002
Last Updated
June 4, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00045422
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 as a Single Agent
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
chronic myelogenous leukemia, BCR-ABL1 positive, chronic phase chronic myelogenous leukemia, childhood chronic myelogenous leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellin Berman, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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