Clinical trial · Interventional
Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia
Phase II Study of Imatinib Mesylate (Gleevec, STI-571) (NSC#716051) and Decitabine (5-AZA-2'-Deoxycitidine) (NSC#127716), in Chronic Myelogenous Leukemia in Accelerated and Blastic Phases
- 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)
This phase II trial is studying how well giving imatinib mesylate together with decitabine works in treating patients with accelerated or blast phase chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving imatinib mesylate together with decitabine may kill more cancer cells
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Accelerated Phase Chronic Myelogenous Leukemia | Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Blastic Phase Chronic Myelogenous Leukemia | Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Childhood Chronic Myelogenous Leukemia | Childhood Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Chronic Myelogenous Leukemia, BCR-ABL1 Positive | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Relapsing Chronic Myelogenous Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| decitabine | Drug | Decitabine | ALIAS |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (imatinib mesylate, decitabine)
- description
- Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: imatinib mesylate
- Drug: decitabine
- Other: laboratory biomarker analysis
Primary outcomes (3)
- measure
- Complete and partial response
- timeFrame
- 6 months
- measure
- Hematologic improvement
- timeFrame
- Up to 1 year
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed chronic myelogenous leukemia * Philadelphia chromosome positive by cytogenetics OR fluorescent in situ hybridization * Accelerated or non-lymphoid blastic phase * Performance status - ECOG 0-2 * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST no greater than 2 times ULN * Creatinine less than 2.0 mg/dL * Normal cardiac function * No New York Heart Association class III or IV heart disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior decitabine * At least 2 weeks since other prior chemotherapy (unless there is evidence of rapidly progressive disease) and recovered * Concurrent hydroxyurea allowed during the first 2 courses of study therapy in patients with rapidly progressing disease * Prior imatinib mesylate allowed * Patients who received at least 4 weeks of prior imatinib mesylate must have failed therapy, as evidenced by resistance after 8 weeks or disease progression * No concurrent grapefruit or grapefruit juice
References
Publications (0)
Data not yet available