Clinical trial · Interventional
STI571 Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
A Phase I/II Trial of STI571 and High-Dose Cytarabine in Myeloid Blast Crisis of Chronic Myeloid Leukemia
NCT00015834CI-TRIAL-00009129completedPhase 1 / Phase 2ClinicalTrials.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)
Phase I/II trial to study the effectiveness of combining STI571 and chemotherapy in treating patients who have chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. STI571 may stop the growth of leukemia cells. Combining chemotherapy and STI571 may kill more cancer cells
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blastic Phase Chronic Myelogenous Leukemia | Blast Phase 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 (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
- Treatment (imatinib mesylate, cytarabine)
- description
- Patients who have not previously received imatinib mesylate receive oral imatinib mesylate daily on days 1-35. Patients who have previously received imatinib mesylate for at least 28 days receive oral imatinib mesylate on days 22-35. All patients receive cytarabine IV over 2 hours every 12 hours on days 29-32. Patients with more than 5% residual blasts in bone marrow on day 28 receive a second course in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: imatinib mesylate
- Drug: cytarabine
Primary outcomes (3)
- measure
- Toxicity according to NCI/NIH Common Toxicity Criteria
- timeFrame
- Up to 2 years
- description
- Described by duration, relatedness to treatment, and action taken.
- measure
- Hematologic response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of chronic myelogenous leukemia in myeloid blast crisis * At least 30% blasts in bone marrow * Philadelphia chromosome positive by cytogenetic analysis * bcr/abl translocation by fluorescent in situ hybridization * Ineligible for or refused allogeneic stem cell transplantation * Not previously treated with imatinib mesylate OR currently receiving imatinib mesylate with stable disease on 2 bone marrow biopsies at least 2 weeks apart * Performance status - ECOG 0-2 * See Disease Characteristics * Bilirubin less than 3 times upper limit of normal (ULN) * AST and ALT less than 3 times ULN * Creatinine less than 2 times ULN * No New York Heart Association class III or IV heart disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and at least 3 months after study for male patients * See Disease Characteristics * No prior allogeneic bone marrow or peripheral blood stem cell transplantation * At least 48 hours since prior interferon alfa * At least 24 hours since prior hydroxyurea * At least 6 weeks since prior busulfan * No other prior chemotherapy for blast crisis (except hydroxyurea) * Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis allowed * At least 4 weeks since prior investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.