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FCR and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT00448019
Recruitment Status : Completed
First Posted : March 15, 2007
Results First Posted : November 2, 2015
Last Update Posted : November 2, 2015
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Lymphocytic Leukemia
Interventions Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Rituximab
Drug: Bevacizumab
Enrollment 64

Recruitment Details Recruitment Period: February 23, 2007 to November 17, 2010. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title FCR + Bevacizumab
Hide Arm/Group Description FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
Period Title: Overall Study
Started 64
Completed 57
Not Completed 7
Reason Not Completed
Withdrawal by Subject             3
Disease progression             1
Death             2
Insurance Issues             1
Arm/Group Title FCR + Bevacizumab
Hide Arm/Group Description FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
Overall Number of Baseline Participants 64
Hide Baseline Analysis Population Description
Two participants included in the study demographics were registered but withdrew prior to receiving treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 64 participants
62
(39 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Female
13
  20.3%
Male
51
  79.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 64 participants
64
1.Primary Outcome
Title Progression Free Survival (PFS) Rate
Hide Description Progression free survival (PFS) was defined as the time from the start of treatment to progression, which included treatment failure, relapse, or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame Baseline up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Five participants of the 62 treated participants were not evaluable for response.
Arm/Group Title FCR + Bevacizumab
Hide Arm/Group Description:
FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
Overall Number of Participants Analyzed 57
Median (Full Range)
Unit of Measure: Months
13.5
(1 to 50)
2.Secondary Outcome
Title Number of Participants With Complete or Partial Response to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated Chronic Lymphocytic Leukemia (CLL)
Hide Description Response criteria for Complete response (CR) - Nodes: None; Liver/Spleen Size: Not palpable; Symptoms: None; polymorphonuclear leukocytes (PMN): >1,500/μl; Platelets >100,000/μl; Hemoglobin (untransfused): >11,0 g/dl; Lymphocytes: <4,000/μl; Bone Marrow aspirate: <30% lymphocytes; Biopsy: No lymphocyte infiltrate; and for Partial Response (PR), Nodes: >/= 50% decrease; Liver/Spleen Size: >/= 50% decrease; Symptoms: None; Platelets >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused): >11.0 g/dl or >50% improvement from baseline; Lymphocytes: >50% decrease; Biopsy: <30% lymphocytes with residual disease on biopsy for nodular PR (NPR).
Time Frame Response assessed after three 4-week courses and after six courses, up to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Five participants of the 62 treated participants were not evaluable for response.
Arm/Group Title FCR + Bevacizumab
Hide Arm/Group Description:
FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 13
Partial Response (PR) 24
Nodular Partial Response (NPR) 8
3.Secondary Outcome
Title Overall Response Rate (ORR) to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated CLL
Hide Description ORR defined as CR and PR response where response criteria for Complete response (CR) - Nodes: None; Liver/Spleen Size: Not palpable; Symptoms: None; polymorphonuclear leukocytes (PMN): >1,500/μl; Platelets >100,000/μl; Hemoglobin (untransfused): >11,0 g/dl; Lymphocytes: <4,000/μl; Bone Marrow aspirate: <30% lymphocytes; Biopsy: No lymphocyte infiltrate; and for Partial Response (PR), Nodes: >/= 50% decrease; Liver/Spleen Size: >/= 50% decrease; Symptoms: None; Platelets >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused): >11.0 g/dl or >50% improvement from baseline; Lymphocytes: >50% decrease; Biopsy: <30% lymphocytes with residual disease on biopsy for nodular PR (NPR).
Time Frame Response assessed after three 4-week courses and after six courses, up to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Five participants of the 62 treated participants were not evaluable for response.
Arm/Group Title FCR + Bevacizumab
Hide Arm/Group Description:
FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: percentage of participants
79
Time Frame Participants evaluated for adverse events at each study visit for study duration, up to six courses of 4 weeks. Overall collection period: May 2011 to September 2014.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FCR + Bevacizumab
Hide Arm/Group Description FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
All-Cause Mortality
FCR + Bevacizumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FCR + Bevacizumab
Affected / at Risk (%)
Total   33/62 (53.23%) 
Blood and lymphatic system disorders   
Anemia  1  1/62 (1.61%) 
Gastrointestinal hemorrhage  1  1/62 (1.61%) 
Gastrointestinal disorders   
Dehydration  1  1/62 (1.61%) 
Diarrhea  1  1/62 (1.61%) 
Esophagitis  1  1/62 (1.61%) 
Nausea  1  1/62 (1.61%) 
Vomiting  1  1/62 (1.61%) 
General disorders   
Death  1  4/62 (6.45%) 
Fatigue  1  1/62 (1.61%) 
Fever  1  2/62 (3.23%) 
Pain  1  1/62 (1.61%) 
Tumor lysis Syndrome  1  1/62 (1.61%) 
Infections and infestations   
Herpes simplex II  1  1/62 (1.61%) 
Infection  1  3/62 (4.84%) 
Neutropenic Fever  1  10/62 (16.13%) 
pneumonia  1  6/62 (9.68%) 
Metabolism and nutrition disorders   
Hypocalcemia  1  1/62 (1.61%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Secondary malignancy  1  9/62 (14.52%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/62 (3.23%) 
Shortness of Breath  1  1/62 (1.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
FCR + Bevacizumab
Affected / at Risk (%)
Total   62/62 (100.00%) 
Blood and lymphatic system disorders   
Neutropenia  1  41/62 (66.13%) 
Thrombocytopenia  1  18/62 (29.03%) 
Anemia  1  9/62 (14.52%) 
Gastrointestinal Hemorrhage  1  2/62 (3.23%) 
Cardiac disorders   
Hypertension  1  1/62 (1.61%) 
Eye disorders   
Blurred vision  1  2/62 (3.23%) 
Gastrointestinal disorders   
Nausea and vomiting  1  22/62 (35.48%) 
General disorders   
Fatigue  1  16/62 (25.81%) 
Infections and infestations   
Infection  1  30/62 (48.39%) 
Nervous system disorders   
Syncope  1  1/62 (1.61%) 
Skin and subcutaneous tissue disorders   
Rash  1  2/62 (3.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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.
Results Point of Contact
Name/Title: MD Anderson Cancer Center Leukemia Department
Organization: The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00448019     History of Changes
Other Study ID Numbers: MDACC-2005-0992
NCI-2010-00591 ( Registry Identifier: NCI CTRP )
First Submitted: March 13, 2007
First Posted: March 15, 2007
Results First Submitted: July 13, 2015
Results First Posted: November 2, 2015
Last Update Posted: November 2, 2015