Trial Outcomes & Findings for A Proof of Concept Study of the Safety, Tolerability, and Efficacy of Avastin (Bevacizumab) in Patients With Chemo-naive Chronic Lymphocytic Leukemia (NCT NCT00754650)
NCT ID: NCT00754650
Last Updated: 2014-06-26
Results Overview
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.
COMPLETED
PHASE2
2 participants
Baseline to the end of treatment (up to 24 weeks)
2014-06-26
Participant Flow
Participant milestones
| Measure |
Bevacizumab 15 mg/kg
Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Bevacizumab 15 mg/kg
Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
|
|---|---|
|
Overall Study
Disease Progression
|
2
|
Baseline Characteristics
A Proof of Concept Study of the Safety, Tolerability, and Efficacy of Avastin (Bevacizumab) in Patients With Chemo-naive Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Bevacizumab 15 mg/kg
n=2 Participants
Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
|
|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to the end of treatment (up to 24 weeks)Population: Intent-to-treat population: All participants who received at least 1 administration of the study drug.
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.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg
n=2 Participants
Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
|
|---|---|
|
Bone Marrow Response
Interim staging
|
-20.0 Percentage of infiltration
Interval -40.0 to 0.0
|
|
Bone Marrow Response
End of treatment
|
-20.0 Percentage of infiltration
Interval -40.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline to the end of treatment (up to 24 weeks)Population: Intent-to-treat population: All participants who received at least 1 administration of the study drug.
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.
Outcome measures
| Measure |
Bevacizumab 15 mg/kg
n=2 Participants
Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
|
|---|---|
|
Best Overall Response (BOR)
Interim staging - Complete response
|
0.0 Percentage of participants
|
|
Best Overall Response (BOR)
Interim staging - Partial response
|
0.0 Percentage of participants
|
|
Best Overall Response (BOR)
Interim staging - Stable disease
|
50.0 Percentage of participants
|
|
Best Overall Response (BOR)
Interim staging - Progressive disease
|
50.0 Percentage of participants
|
|
Best Overall Response (BOR)
End of treatment - Complete response
|
0.0 Percentage of participants
|
|
Best Overall Response (BOR)
End of treatment - Partial response
|
0.0 Percentage of participants
|
|
Best Overall Response (BOR)
End of treatment - Stable disease
|
0.0 Percentage of participants
|
|
Best Overall Response (BOR)
End of treatment - Progressive disease
|
100.0 Percentage of participants
|
Adverse Events
Bevacizumab 15 mg/kg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bevacizumab 15 mg/kg
n=2 participants at risk
Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
100.0%
2/2
Intent-to-treat population: All participants who received at least 1 administration of the study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
1/2
Intent-to-treat population: All participants who received at least 1 administration of the study drug.
|
|
General disorders
Fatigue
|
50.0%
1/2
Intent-to-treat population: All participants who received at least 1 administration of the study drug.
|
|
Vascular disorders
Hypertension
|
50.0%
1/2
Intent-to-treat population: All participants who received at least 1 administration of the study drug.
|
Additional Information
Medical Communications
Hoffmann-La Roche
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER