Clinical trial · Interventional
Dose Escalation Study of Gleevec and Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia Patients
A Phase I-II Trial of Gleevec (Imatinib Mesylate) in Combination With Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia (CLL) Patients
NCT00558961CI-TRIAL-00065023GL-CLB-001terminatedPhase 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
Why stopped (as posted): Unsatisfactory enrollment
Summary
Brief summary (as posted)
The purpose of this study is to determine maximum tolerated dose of Gleevec in combination with Chlorambucil in previously treated CLL patients.
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 |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gleevec and Chlorambucil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- I
- description
- Gleevec Chlorambucil
- interventionNames
- Drug: Gleevec and Chlorambucil
Primary outcomes (1)
- measure
- Measure number of patients at maximum tolerated dose of Gleevec in combination with chlorambucil
- timeFrame
- 1 month
Secondary outcomes (3)
- measure
- Report adverse events as a measure of safety
- timeFrame
- 6 months
- measure
- Report response to treatment as a measure of efficacy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * B-cell chronic lymphocytic leukemia (a) Rai stage 0-II with indication for treatment by NCI Working Group Criteria: or (b) Rai stage III or IV. * Received a minimum of one prior chemotherapy regimen. Prior treatment with corticosteroids, immunotherapies, monoclonal antibodies or radiation therapy is permitted. * White blood cell count \> 25 x 10\^9/L * ECOG 0, 1,or 2. * Adequate renal and hepatic function * Platelets \> 75 x 10\^9/L, transfusion independent. * Neutrophils \> 1.0 x 10\^9/L, transfusion independent Exclusion Criteria: * Documented prolymphocytic leukemia (PLL; prolymphocytes, 55% in blood) * Active cardiovascular disease as defined by NYHA class III-IV categorization. * Intercurrent illness or medical condition precluding safe administration of ribavirin. * Concurrent use of chronic steroids, except as replacement therapy for adrenal insufficiency * Known infection with HIV, Hepatitis B or C. * Concurrent malignancy (other than resected basal or squamous cell skin cancers or in-situ carcinoma). * Received any previous therapy for CLL within 28 days prior to study entry.
References
Publications (1)
- BACKGROUNDAloyz R, Grzywacz K, Xu ZY, Loignon M, Alaoui-Jamali MA, Panasci L. Imatinib sensitizes CLL lymphocytes to chlorambucil. Leukemia. 2004 Mar;18(3):409-14. doi: 10.1038/sj.leu.2403247. PMID 14712290