A Proof of Concept Study of the Safety, Tolerability, and Efficacy of Avastin (Bevacizumab) in Patients With Chemo-naive Chronic Lymphocytic Leukemia

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00754650
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 5.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphocytic Leukemia, Chronic	Drug: Bevacizumab	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ML21206 - Bevacizumab in Chronic Lymphocytic Leukemia: A Proof of Concept Study
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bevacizumab 15 mg/kg Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.	Drug: Bevacizumab; Bevacizumab was supplied as a sterile liquid in single-use vials.; Other Names: Avastin

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Salzburg		Austria	5020

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00754650
• Other Study ID Numbers: ML21206; 2007-004824-19
• First Posted: Sep 18, 2008
• Last Update Posted: Jun 26, 2014
• Last Verified: May 1, 2014

• Additional relevant MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Bevacizumab

Study Results

Participant Flow

Arm/Group Title	Bevacizumab 15 mg/kg
Arm/Group Description	Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
Period Title: Overall Study
STARTED	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Bevacizumab 15 mg/kg
Arm/Group Description	Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
Overall Participants	2
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.0 (9.9)
Sex: Female, Male (Count of Participants)
Female	1 50%
Male	1 50%

Outcome Measures

1. Primary Outcome

Title	Bone Marrow Response
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.
Time Frame	Baseline to the end of treatment (up to 24 weeks)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All participants who received at least 1 administration of the study drug.

Arm/Group Title	Bevacizumab 15 mg/kg
Arm/Group Description	Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
Measure Participants	2
Interim staging	-20.0
End of treatment	-20.0

2. Secondary Outcome

Title	Best Overall Response (BOR)
Description	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)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: All participants who received at least 1 administration of the study drug.

Arm/Group Title	Bevacizumab 15 mg/kg
Arm/Group Description	Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
Measure Participants	2
Interim staging - Complete response	0.0 0%
Interim staging - Partial response	0.0 0%
Interim staging - Stable disease	50.0 2500%
Interim staging - Progressive disease	50.0 2500%
End of treatment - Complete response	0.0 0%
End of treatment - Partial response	0.0 0%
End of treatment - Stable disease	0.0 0%
End of treatment - Progressive disease	100.0 5000%

Adverse Events

Adverse Event Reporting Description	Intent-to-treat population: All participants who received at least 1 administration of the study drug.
Arm/Group Title	Bevacizumab 15 mg/kg
Arm/Group Description	Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.
All Cause Mortality
	Bevacizumab 15 mg/kg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Bevacizumab 15 mg/kg
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Bevacizumab 15 mg/kg
	Affected / at Risk (%)	# Events
Total	2/2 (100%)
Blood and lymphatic system disorders
Thrombocytopenia	1/2 (50%)
General disorders
Fatigue	1/2 (50%)
Infections and infestations
Nasopharyngitis	2/2 (100%)
Vascular disorders
Hypertension	1/2 (50%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.