Clinical trial · Interventional
Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
A Phase II Study To Determine The Anti-Leukemic Effects Of STI571 In Combination With Ara-C In Patients With Chronic Myelogenous Leukemia In Chronic Phase
- 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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: This phase II trial is studying giving imatinib mesylate together with cytarabine to see how well it works in treating patients with chronic phase 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 |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cytarabine/ Imatinib Mesylate
- interventionNames
- Drug: cytarabine
- Drug: imatinib mesylate
Primary outcomes (1)
- measure
- The Rate of Major Cytogenetic Response at 6 Months
- timeFrame
- 6 months
- description
- Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.
Secondary outcomes (4)
- measure
- The Rate of Complete Cytogenetic Response at 6 Months
- timeFrame
- 6 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Cytogenetically confirmed chronic phase 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 * Philadelphia chromosome positive * No more than 6 months since initial diagnosis * No presence of leukemia beyond the bone marrow, blood, liver, or spleen (i.e., chloroma) * Refused allogeneic stem cell transplantation as first-line therapy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Eastern Cooperative Oncology Group (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 effective barrier contraception during and for at least 3 months after study participation * No other serious uncontrolled medical condition * No history of noncompliance to medical regimens or potential unreliability PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior biologic therapy for CML Chemotherapy: * No prior chemotherapy for CML except hydroxyurea * Concurrent hydroxyurea to control blood counts during first 3 months of treatment allowed * No other concurrent chemotherapy Endocrine therapy: * No prior endocrine therapy for CML Radiotherapy: * No prior radiotherapy for CML Surgery: * Not specified Other: * More than 28 days since prior investigational anticancer agents * Prior anagrelide hydrochloride for CML allowed * Concurrent anagrelide hydrochloride to control blood counts during first 3 months of treatment allowed * No concurrent grapefruit juice or grapefruit
References
Publications (0)
Data not yet available