Bevacizumab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00290810
First received: February 9, 2006
Last updated: April 21, 2014
Last verified: April 2012
Results First Received: March 22, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: B-cell Chronic Lymphocytic Leukemia
Refractory Chronic Lymphocytic Leukemia
Intervention: Biological: bevacizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirteen patients were accrued to the bevacizumab trial between December 2005 and March 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient never received protocol treatment due to a high protein:creatinine ratio and high 24-hour urine protein excretion. Accordingly, 12 eligible patients were included in the outcome analysis.

Reporting Groups
  Description
Treatment (Monoclonal Antibody Therapy) Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Treatment (Monoclonal Antibody Therapy)  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (Monoclonal Antibody Therapy) Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    Treatment (Monoclonal Antibody Therapy)  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Median ( Full Range )
  73  
  ( 60 to 80 )  
Gender  
[units: participants]
 
Female     7  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures
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1.  Primary:   Number of Patients With Confirmed Objective Status of Complete Response (CR), Complete Clinical Response (CCR), Nodular Partial Response (nPR), or Partial Response (PR).   [ Time Frame: Up to 5 years ]

2.  Secondary:   Toxicity Associated With This Regimen in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL).   [ Time Frame: From the date of registration to the to the date of last treatment evaluation, median number of days on treatment was 56 days. ]

3.  Secondary:   Overall Survival   [ Time Frame: From the date of registration to the date of the event (i.e., death or the date of last follow-up), up to 5 years. ]

4.  Secondary:   Time to Progression   [ Time Frame: From the date of registration to the date of the event (i.e., death or disease progression) or the date of last follow-up, up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Tait Shanafelt, M.D.
Organization: Mayo Clinic
e-mail: shanafelt.tait@mayo.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00290810     History of Changes
Obsolete Identifiers: NCT01646996, NCT01664364
Other Study ID Numbers: NCI-2009-00137, NCI-2009-00137, MAYO-MC048C, NCI-7211, CDR0000459933, MC048C, 7211, P30CA015083, N01CM62205, N01CM62207
Study First Received: February 9, 2006
Results First Received: March 22, 2013
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration