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

June 4, 2013 updated by: Memorial Sloan Kettering Cancer Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Ellin Berman, MD, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

October 1, 2003

Study Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

September 6, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-013
  • CDR0000256469 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-G02-2105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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