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

NCT00015847 | Terminated Phase 2 Results DMC

• 5 other identifiers: CDR0000068443OHSU-6263OHSU-409NCI-2794OHSU-HEM-00072-LX
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Imatinib mesylate and interferon alfa may interfere with the growth of the cancer cells. Combining imatinib mesylate with interferon alfa may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining imatinib mesylate with interferon alfa in treating patients who have chronic myelogenous leukemia.

Conditions

Leukemia

Keywords

relapsing chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; Philadelphia chromosome positive chronic myelogenous leukemia

Outcome Measures

Primary Outcomes (6)

• Complete Cytogenetic Response at 6 and 12 Months (Phase II)

  Cytogenetic response in terms of the percentage of Ph chromosome positive metaphases in bone marrow is defined as follows: Complete\* (0% Ph-positive cells) Partial\* (1-34%) Minor (35-95%) None (96-100%).

  At 6 and 12 months during phase II

• Minor Cytogenetic Response at 6 and 12 Months (Phase II)

  At 6 and 12 months during phase II

• Complete Hematologic Response at 6 and 12 Months (Phase II)

  At 6 and 12 months during phase II

• Molecular Response in Patients With Complete Cytogenetic Response at 6 and 12 Months (Phase II)

  At 6 and 12 months during phase II

• Treatment-related Toxicity (i.e., Grade 3 or 4 Nonhematologic Toxicity) as Measured by NCI CTCAE v3.0 (Phase I)

  1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death

  12 Months

• Major Cytogenetic Response After 6 and 12 Months of Treatment.

  Cytogenetic response in terms of the percentage of Ph chromosome positive metaphases in bone marrow is defined as follows: Complete\* (0% Ph-positive cells) Partial\* (1-34%) Minor (35-95%) None (96-100%). \*Major cytogenetic response includes complete and partial cytogenetic response.

  6 and 12 months after treatment

Interventions

recombinant interferon alfa BIOLOGICAL

IFN-α will be given at a dose ranging up to 5 MIU daily via subcutaneous injection.

imatinib mesylate DRUG

Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.

Also known as: STI571

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Cytogenetically confirmed chronic myelogenous leukemia (CML) * Less than 15% blasts in peripheral blood or bone marrow * Less than 30% blasts and promyelocytes in peripheral blood or bone marrow * Less than 20% basophils in blood or bone marrow * Platelet count at least 100,000/mm\^3 * No leukemia beyond bone marrow, blood, liver, or spleen * No chloroma * Phase I (closed to accrual as of 7/9/03): * Philadelphia (Ph) chromosome-positive CML in chronic phase * Phase II: * Newly diagnosed Ph chromosome-positive CML in chronic phase * Initial diagnosis within 6 months of study * No prior therapy for CML except hydroxyurea and/or anagrelide hydrochloride * Phase I (closed to accrual as of 7/9/03) and II: * No identified sibling donors where allogeneic stem cell transplantation is elected as first-line therapy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST or ALT no greater than 2 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No New York Heart Association class III or IV heart disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 methods of effective barrier contraception during and for at least 3 months after study participation * No other serious uncontrolled medical condition * No autoimmune disease * No prior noncompliance to medical regimens or potential unreliability * No prior grade 3 or greater non-hematologic toxicity due to prior interferon (phase I \[closed to accrual as of 7/9/03\]) PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior bone marrow or peripheral blood stem cell transplantation * At least 2 weeks since prior interferon alfa (phase I \[closed to accrual as of 7/9/03\]) Chemotherapy: * See Disease Characteristics * At least 6 weeks since prior busulfan (phase I \[closed to accrual as of 7/9/03\] ) * At least 2 weeks since prior cytarabine (phase I \[closed to accrual as of 7/9/03\]) * No concurrent chemotherapy * Concurrent hydroxyurea allowed during the first 3 months of study Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * At least 4 weeks since prior investigational agents other than imatinib mesylate (phase I \[closed to accrual as of 7/9/03\]) * No concurrent grapefruit juice * Concurrent anagrelide hydrochloride allowed during the first 3 months of study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Interferon-alpha; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

Early termination; 12 month follow-up was not carried out.

Results Point of Contact

• Title: Dr. Brian Druker
• Organization: OHSU Knight Cancer Institute

trials@ohsu.edu

503-494-7999

Study Officials

• Brian J. Druker, MD

  OHSU Knight Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: January 27, 2003
• Study Start: April 1, 2001
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 22, 2025
• Results First Posted: August 20, 2012

Record last verified: 2025-08

Locations

US (2)