Clinical trial · Interventional
Interferon Alfa and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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 allowedReferences
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