Clinical trial · Interventional
Bortezomib in Treating Patients With Chronic Myelogenous Leukemia
Phase II Study of a Proteasome Inhibitor, PS-341 (NSC 681239) in Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase
NCT00023881CI-TRIAL-00035763terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of efficacy
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. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have chronic myelogenous leukemia in chronic or accelerated phase.
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 |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of Philadelphia (Ph) chromosome-positive chronic myelogenous leukemia (CML) in chronic or accelerated phase, defined as having any of the following: * Peripheral blood (PB) or bone marrow (BM) blasts at least 10% but less than 30% * PB or BM blasts and promyelocytes at least 20% * PB or BM basophils at least 20% * Progressive splenomegaly (at least 10 cm confirmed twice at least 4 weeks apart or 50% increase in splenomegaly over 4 weeks) * Clonal evolution defined as the presence of additional cytogenetic abnormalities other than the Ph chromosome * Thrombocytopenia (platelet count less than 100,000/mm\^3) unrelated to therapy * Hemoglobin less than 7 g/dL unrelated to therapy or bleeding * Failed prior treatment with imatinib mesylate or intolerant, unable, or unwilling to receive it * Ineligible for higher-priority or higher-efficacy regimens or protocols * No blastic phase CML PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy: * At least 18 weeks Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin no greater than 1.5 mg/dL Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Other: * No other concurrent illness that would preclude study entry * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No more than 2 prior cytotoxic regimens in addition to imatinib mesylate and/or hydroxyurea * At least 4 weeks since prior chemotherapy and recovered * Concurrent hydroxyurea and/or anagrelide allowed during first 2 courses Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered Surgery: * Not specified Other: * See Disease Characteristics * See Chemotherapy * At least 24 hours since prior imatinib mesylate * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.