A Proof of Concept Study of the Safety, Tolerability, and Efficacy of Avastin (Bevacizumab) in Patients With Chemo-naive Chronic Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00754650|
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : June 26, 2014
Last Update Posted : June 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Lymphocytic Leukemia, Chronic||Drug: Bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ML21206 - Bevacizumab in Chronic Lymphocytic Leukemia: A Proof of Concept Study|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
Experimental: Bevacizumab 15 mg/kg
Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
Bevacizumab was supplied as a sterile liquid in single-use vials.
Other Name: Avastin
- Bone Marrow Response [ Time Frame: Baseline to the end of treatment (up to 24 weeks) ]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.
- Best Overall Response (BOR) [ Time Frame: Baseline to the end of treatment (up to 24 weeks) ]The percentage of participants in each BOR category (complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)) is reported. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754650
|Salzburg, Austria, 5020|
|Study Director:||Clinical Trials||Hoffmann-La Roche|