Clinical trial · Interventional
Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
A Phase I/II Dose-Finding Study to Determine the Safety, Tolerability, and Anti-Leukemic Effects of STI571 (NSC 716051) in Combination With Interferon-alpha in Patients With Chronic Myelogenous Leukemia in Chronic Phase
NCT00015847CI-TRIAL-00094042terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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: 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
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 |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Complete Cytogenetic Response at 6 and 12 Months (Phase II)
- timeFrame
- At 6 and 12 months during phase II
- description
- 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%).
- measure
- Minor Cytogenetic Response at 6 and 12 Months (Phase II)
- timeFrame
- At 6 and 12 months during phase II
- measure
- Complete Hematologic Response at 6 and 12 Months (Phase II)
- timeFrame
- At 6 and 12 months during phase II
- measure
- Molecular Response in Patients With Complete Cytogenetic Response at 6 and 12 Months (Phase II)
- timeFrame
- At 6 and 12 months during phase II
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.