Clinical trial · Interventional
STI571 in Treating Patients With Chronic Myelogenous Leukemia in Blast Crisis
An Open-Label Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Blast Crisis
NCT00006475CI-TRIAL-00009540completedPhase 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)
RATIONALE: STI571 may interfere with the growth of cancer cells and may be an effective treatment for leukemia. PURPOSE: Phase II trial to study the effectiveness of STI571 in treating patients who have chronic myelogenous leukemia in blast crisis.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Diagnosis of chronic myelogenous leukemia (CML) in blast crisis, defined by at least one of the following: 30% blasts in peripheral blood and/or bone marrow Flow cytometry criteria Extramedullary disease other than spleen, lymph node, and/or liver involvement Newly diagnosed CML in blast crisis OR CML in blast crisis with prior therapy for accelerated or blastic phases Philadelphia (Ph) chromosome positive OR Ph chromosome negative and Bcr/Abl positive PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: SGOT and SGPT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver involvement) Bilirubin no greater than 3 times ULN Renal: Creatinine no greater than 2 times ULN Cardiovascular: No grade 3 or 4 cardiac disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for women and for at least 3 months after study for men No history of noncompliance with medical regimens No serious concurrent medical condition PRIOR CONCURRENT THERAPY: Biologic therapy: At least 48 hours since prior interferon alfa At least 6 weeks since prior hematopoietic stem cell transplantation No concurrent anticancer biologic therapy Chemotherapy: At least 6 weeks since prior busulfan At least 24 hours since prior hydroxyurea At least 2 weeks since prior homoharringtonine At least 1 week since prior low-dose cytarabine (less than 30 mg/m2 every 12-24 hours daily) At least 2 weeks since prior moderate-dose cytarabine (100-200 mg/m2 for 5-7 days) At least 4 weeks since prior high-dose cytarabine (1-3 g/m2 every 12-24 hours for 6-12 doses) At least 3 weeks since prior anthracyclines, mitoxantrone, or etoposide No concurrent anticancer chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 4 weeks since other prior investigational agents No other concurrent anticancer investigational agents
References
Publications (2)
- RESULTHensley ML, van Hoomissen IC, Krahnke T, et al.: Imatinib in chronic myeloid leukemia (CML): outcomes in >7000 patients treated on expanded access program (EAP). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2328, 2003.
- RESULTvan Hoomissen IC, Hensley ML, Krahnke T, et al.: Imatinib expanded access program (EAP): results of treatment in >7000 patients with chronic myeloid leukemia (CML). [Abstract] Blood 102 (11): A-3370, 2003.