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Trial record 20 of 42 for:    LENALIDOMIDE AND Leukemia AND SLL

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.
Hide 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
Layout table for Results Point of Contact information
Name/Title: Alessandra Ferrajoli, MD/Professor, Leukemia
Organization: The University of Texas (UT) MD Anderson Cancer Center
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
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