Lymphocytic Leukemia, Chronic
Conditions
Brief summary
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.
Interventions
DRUGBevacizumab
Bevacizumab was supplied as a sterile liquid in single-use vials.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Marrow Response | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Response (BOR) | 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. |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab 15 mg/kg Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Disease Progression | 2 |
Baseline characteristics
| Characteristic | Bevacizumab 15 mg/kg |
|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 9.9 |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Bone Marrow Response
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Bevacizumab 15 mg/kg | Bone Marrow Response | Interim staging | -20.0 Percentage of infiltration |
| Bevacizumab 15 mg/kg | Bone Marrow Response | End of treatment | -20.0 Percentage of infiltration |
Secondary
Best Overall Response (BOR)
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab 15 mg/kg | Best Overall Response (BOR) | End of treatment - Stable disease | 0.0 Percentage of participants |
| Bevacizumab 15 mg/kg | Best Overall Response (BOR) | Interim staging - Complete response | 0.0 Percentage of participants |
| Bevacizumab 15 mg/kg | Best Overall Response (BOR) | Interim staging - Partial response | 0.0 Percentage of participants |
| Bevacizumab 15 mg/kg | Best Overall Response (BOR) | Interim staging - Stable disease | 50.0 Percentage of participants |
| Bevacizumab 15 mg/kg | Best Overall Response (BOR) | Interim staging - Progressive disease | 50.0 Percentage of participants |
| Bevacizumab 15 mg/kg | Best Overall Response (BOR) | End of treatment - Complete response | 0.0 Percentage of participants |
| Bevacizumab 15 mg/kg | Best Overall Response (BOR) | End of treatment - Partial response | 0.0 Percentage of participants |
| Bevacizumab 15 mg/kg | Best Overall Response (BOR) | End of treatment - Progressive disease | 100.0 Percentage of participants |