Clinical trial · Interventional
A Proof of Concept Study of the Safety, Tolerability, and Efficacy of Avastin (Bevacizumab) in Patients With Chemo-naive Chronic Lymphocytic Leukemia
ML21206 - Bevacizumab in Chronic Lymphocytic Leukemia: A Proof of Concept Study
NCT00754650CI-TRIAL-00014943completedPhase 2Results postedClinicalTrials.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)
This single arm study evaluated the bone marrow response, safety, and tolerability of 6 months treatment with Avastin (bevacizumab) monotherapy in patients with chronic lymphocytic leukemia. Patients received 8 cycles (21 days duration) of Avastin monotherapy (15mg/kg) with 6 months of follow-up.
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 |
|---|---|---|---|
| Lymphocytic Leukemia, Chronic | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab 15 mg/kg
- description
- Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
- interventionNames
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Bone Marrow Response
- timeFrame
- Baseline to the end of treatment (up to 24 weeks)
- description
- Bone marrow response was defined as the change in percentage of infiltration at the interim staging (after 4 cycles of treatment) and the end of treatment.
Secondary outcomes (1)
- measure
- Best Overall Response (BOR)
- timeFrame
- Baseline to the end of treatment (up to 24 weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients, ≥ 18 years of age. * B-chronic lymphocytic leukemia not yet requiring treatment. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * No previous treatment of chronic lymphocytic leukemia (CLL) by chemotherapy, radiotherapy, or immunotherapy. * Life expectancy \> 6 months. Exclusion Criteria: * Central nervous system (CNS) involvement by lymphoma or any evidence of spinal cord compression. * Computed tomography (CT) scan based evidence of tumor invading major blood vessels. * Gastrointestinal (GI) tract involvement by CLL. * Active viral, bacterial, or fungal infection. * Uncontrolled hypertension, cerebrovascular accident/stroke (≤ 6 months prior to randomization), myocardial infarction (≤ 6 months prior to randomization), unstable angina (≥ New York Heart Association (NYHA) Grade IV), thrombosis within 6 months before enrollment, NYHA Grade II congestive heart failure, or serious cardiac arrhythmia requiring ongoing medication.
References
Publications (0)
Data not yet available
No reference posted for this study.