Lymphocytic Leukemia, ChronicPhase 2NCT00754650
A Proof of Concept Study of the Safety, Tolerability, and Efficacy of Avastin (Bevacizumab) in Patients With Chemo-naive Chronic Lymphocytic Leukemia
A Phase 2 study testing Bevacizumab in people with Lymphocytic Leukemia, Chronic, run by Hoffmann-La Roche at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphocytic Leukemia, Chronic
- What is being tested?
- Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2008to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ML21206 - Bevacizumab in Chronic Lymphocytic Leukemia: A Proof of Concept Study
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
- Lymphocytic Leukemia, Chronic
- Being tested
- Bevacizumab
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Bevacizumab was supplied as a sterile liquid in single-use vials.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab 15 mg/kg | Experimental | Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to the end of treatment (up to 24 weeks)
Secondary outcomes (1)
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.
Measured: Baseline to the end of treatment (up to 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lymphocytic Leukemia, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754650
- Sponsor's protocol ID
- ML21206
- Other IDs
- 2007-004824-19
- Status last verified
- May 2014
- First submitted
- 17 Sep 2008
- Last updated
- 26 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ML21206 - Bevacizumab in Chronic Lymphocytic Leukemia: A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT00754650
- Acronym / sponsor ID
- ML21206
- Conditions
- Lymphocytic Leukemia, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Posted 26 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab 15 mg/kg | Experimental | Drug: BevacizumabParticipants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: AvastinBevacizumab was supplied as a sterile liquid in single-use vials. | Drug | Bevacizumab 15 mg/kg |
Primary outcome
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.
1 secondary outcome
Best Overall Response (BOR)
Time frame: Baseline to the end of treatment (up to 24 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab in people with Lymphocytic Leukemia, Chronic, run by Hoffmann-La Roche at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Marrow Response (time frame: Baseline to the end of treatment (up to 24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.