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Lenalidomide and Rituximab as Treatment of Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00759603
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : August 27, 2015
Last Update Posted : August 27, 2015
Sponsor:
Collaborator:
Celgene Corporation
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
Conditions Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Interventions Drug: Lenalidomide
Drug: Rituximab
Enrollment 60
Recruitment Details Recruitment Period: September 22, 2008 to November 02, 2009. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details One of the 60 participants enrolled was excluded from the trial before any treatment assignment.
Arm/Group Title Lenalidomide + Rituximab
Hide Arm/Group Description Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
Period Title: Overall Study
Started 59
Completed 59
Not Completed 0
Arm/Group Title Lenalidomide + Rituximab
Hide Arm/Group Description Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
Overall Number of Baseline Participants 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 59 participants
62
(42 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Female
13
  22.0%
Male
46
  78.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 59 participants
59
1.Primary Outcome
Title Overall Participant Response Rate: Percentage of Participants With Complete + Partial Response According to Revised National Cancer Institute-sponsored Working Group Guidelines
Hide Description Complete response: Absence lymphadenopathy, hepatomegaly or splenomegaly & constitutional symptoms; Normal complete blood count (CBC) exhibited by polymorphonuclear leukocytes>1500/µL, platelets>100,000/µL, hemoglobin>11.0 g/dL (untransfused); lymphocyte count <5,000/µL; Bone marrow aspirate & biopsy normocellular for age with <30% nucleated cells lymphocytes; Absence Lymphoid nodules. Fulfillment CR criteria after induction with exception of treatment related persistent cytopenia & bone marrow lymphoid nodules both considered partial response; Partial response: Requires 50% decrease in peripheral lymphocytes from pre-treatment, 50% reduction in lymphadenopathy, &/or 50% reduction in splenomegaly/hepatomegaly for 2+ months from therapy completion. Additionally one following from pre-treatment: Polymorphonuclear leukocytes 1,500/µL or 50% improvement; Platelets>100,000/µL or 50% improvement; Hemoglobin>11.0 g/dL (untransfused) or 50% improvement.
Time Frame Responses assessed after 12 cycles, up to 48 weeks with interim assessments performed after 3, 6 and 12 cycles.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide + Rituximab
Hide Arm/Group Description:
Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: Percentage of Participants
66
Time Frame Adverse event collected through 12 cycles of 28-days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide + Rituximab
Hide Arm/Group Description Oral Lenalidomide 10 mg/day started on Day 9 of cycle 1; Rituximab 375 mg/m^2 intravenously on Day 1, Day 8, Day 15 and Day 22 then continued once every four weeks during cycles 3-12 (+ 7 days). Rituximab not given in Cycle 2. Treatment duration twelve cycles.
All-Cause Mortality
Lenalidomide + Rituximab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide + Rituximab
Affected / at Risk (%) # Events
Total   29/59 (49.15%)    
Blood and lymphatic system disorders   
Autoimmune hemolytic anemia  1  1/59 (1.69%)  1
Evan's syndrome  1  1/59 (1.69%)  1
Left leg swelling  1  1/59 (1.69%)  1
Cardiac disorders   
Acute Myocardial Infarction  1  1/59 (1.69%)  1
Atrial Fibrillation  1  2/59 (3.39%)  3
Cardiac arrhythmia  1  1/59 (1.69%)  1
Cardiac other  1  1/59 (1.69%)  1
Left ventricular diastolic dysfunction  1  1/59 (1.69%)  1
Left ventricular systolic dysfunction  1  1/59 (1.69%)  1
Thrombus  1  1/59 (1.69%)  1
Gastrointestinal disorders   
Abdominal mass  1  1/59 (1.69%)  1
Constipation  1  1/59 (1.69%)  1
Diarrhea  1  1/59 (1.69%)  1
General disorders   
Abdominal pain  1  1/59 (1.69%)  1
Death  1  2/59 (3.39%)  2
Fever  1  2/59 (3.39%)  3
Tumor lysis syndrome  1  1/59 (1.69%)  1
Infections and infestations   
Acute bronchitis  1  1/59 (1.69%)  1
Catheter related infection  1  1/59 (1.69%)  1
Neutropenic fever  1  7/59 (11.86%)  8
Perianal infection  1  1/59 (1.69%)  1
Pulmonary infection RSV  1  1/59 (1.69%)  1
Skin infection  1  2/59 (3.39%)  2
Enteritis  1  2/59 (3.39%)  2
Lung Infection  1  9/59 (15.25%)  17
Metabolism and nutrition disorders   
Hypokalemia  1  1/59 (1.69%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Secondary malignancy  1  3/59 (5.08%)  3
Nervous system disorders   
Syncope  1  1/59 (1.69%)  1
Renal and urinary disorders   
Acute renal failure  1  1/59 (1.69%)  1
Surgical and medical procedures   
Elective surgery, right knee  1  1/59 (1.69%)  1
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 5%
Lenalidomide + Rituximab
Affected / at Risk (%) # Events
Total   59/59 (100.00%)    
Blood and lymphatic system disorders   
Neutropenia  1  43/59 (72.88%)  43
Thrombocytopenia  1  20/59 (33.90%)  20
Anemia  1  9/59 (15.25%)  9
Peripheral edema  1  6/59 (10.17%)  6
Gastrointestinal disorders   
Diarrhea  1  21/59 (35.59%)  21
Constipation  1  11/59 (18.64%)  11
Nausea  1  10/59 (16.95%)  10
Anorexia  1  9/59 (15.25%)  9
Heartburn  1  6/59 (10.17%)  6
General disorders   
fatigue  1  32/59 (54.24%)  32
Tumor flare  1  16/59 (27.12%)  16
Gastrointestinal pain  1  7/59 (11.86%)  7
Headache  1  6/59 (10.17%)  6
Infections and infestations   
Penumonia/bronchitis  1  6/59 (10.17%)  6
Neutropenic fever  1  6/59 (10.17%)  6
Metabolism and nutrition disorders   
Metabolic or laboratory  1  9/59 (15.25%)  9
Hyperglycemia  1  8/59 (13.56%)  8
Hypomagnesemia  1  7/59 (11.86%)  7
Hyperbilirubinemia  1  7/59 (11.86%)  7
Musculoskeletal and connective tissue disorders   
Arthralgia  1  10/59 (16.95%)  10
Nervous system disorders   
Sensory neuropathy  1  14/59 (23.73%)  14
Neurologic other  1  10/59 (16.95%)  10
Renal and urinary disorders   
Elevated serum creatinine  1  7/59 (11.86%)  7
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  6/59 (10.17%)  6
Skin and subcutaneous tissue disorders   
Rash  1  13/59 (22.03%)  13
Pruritus  1  8/59 (13.56%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Alessandra Ferrajoli, MD/Professor, Leukemia
Organization: The University of Texas (UT) MD Anderson Cancer Center
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00759603     History of Changes
Other Study ID Numbers: 2007-0208
NCI-2012-01674 ( Registry Identifier: NCI CTRP )
First Submitted: September 24, 2008
First Posted: September 25, 2008
Results First Submitted: July 27, 2015
Results First Posted: August 27, 2015
Last Update Posted: August 27, 2015