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Rituximab and/or Lenalidomide in Treating Patients With Follicular Non-Hodgkin's Lymphoma That is Not Refractory to Rituximab

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ClinicalTrials.gov Identifier: NCT00238238
Recruitment Status : Completed
First Posted : October 13, 2005
Results First Posted : February 7, 2017
Last Update Posted : March 15, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Interventions Biological: rituximab
Drug: lenalidomide
Enrollment 97
Recruitment Details Between October 2006 and April 2011, 97 participants were accrued to the study.
Pre-assignment Details Three participants assigned to the lenalidomide arm alone arm never began treatment, and the rituximab arm was discontinued early.
Arm/Group Title Arm I - Rituximab Arm II - Lenalidomide Arm III - Lenalidomide and Rituximab
Hide Arm/Group Description Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22. Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days. Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
Period Title: Overall Study
Started 3 48 46
Completed 3 45 46
Not Completed 0 3 0
Reason Not Completed
Withdrawal by Subject             0             3             0
Arm/Group Title Arm I - Rituximab Arm II - Lenalidomide Arm III - Lenalidomide and Rituximab Total
Hide Arm/Group Description Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22. Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days. Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29. Total of all reporting groups
Overall Number of Baseline Participants 0 45 46 91
Hide Baseline Analysis Population Description
Three participants assigned to the lenalidomide arm alone arm never began treatment. Participants on the rituximab arm was discontinued early; in order to avoid potential identification of patients, no results will be entered for this arm.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 0 participants 45 participants 46 participants 91 participants
63
(34 to 85)
64
(36 to 89)
63
(34 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 45 participants 46 participants 91 participants
Female
18
  40.0%
19
  41.3%
37
  40.7%
Male
27
  60.0%
27
  58.7%
54
  59.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 45 participants 46 participants 91 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   2.2%
1
   1.1%
Native Hawaiian or Other Pacific Islander
1
   2.2%
0
   0.0%
1
   1.1%
Black or African American
3
   6.7%
1
   2.2%
4
   4.4%
White
37
  82.2%
44
  95.7%
81
  89.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   8.9%
0
   0.0%
4
   4.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 45 participants 46 participants 91 participants
45 46 91
1.Primary Outcome
Title Overall Response Rate
Hide Description Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a >/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.
Time Frame Duration of treatment (12 cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants assigned to the lenalidomide arm alone arm never began treatment, and the rituximab arm was discontinued early.
Arm/Group Title Arm I - Rituximab Arm II - Lenalidomide Arm III - Lenalidomide and Rituximab
Hide Arm/Group Description:
Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
Overall Number of Participants Analyzed 0 45 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
53.3
(37.9 to 68.3)
76.1
(61.2 to 87.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm II - Lenalidomide, Arm III - Lenalidomide and Rituximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Time to Progression
Hide Description Time to progression (TTP) is defined as the time from study entry until progression or death without progression. The median TTP with 95% CI was estimated using the Kaplan-Meier method.
Time Frame Up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants assigned to the lenalidomide arm alone arm never began treatment, and the rituximab arm was discontinued early.
Arm/Group Title Arm I - Rituximab Arm II - Lenalidomide Arm III - Lenalidomide and Rituximab
Hide Arm/Group Description:
Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
Overall Number of Participants Analyzed 0 45 46
Median (95% Confidence Interval)
Unit of Measure: years
1.1
(0.8 to 1.2)
2
(1.7 to 3.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm II - Lenalidomide, Arm III - Lenalidomide and Rituximab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description 90 participants, on Arms II and III, were evaluable for adverse events.
 
Arm/Group Title Arm I - Rituximab Arm II - Lenalidomide Arm III - Lenalidomide and Rituximab
Hide Arm/Group Description Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22. Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days. Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
All-Cause Mortality
Arm I - Rituximab Arm II - Lenalidomide Arm III - Lenalidomide and Rituximab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Arm I - Rituximab Arm II - Lenalidomide Arm III - Lenalidomide and Rituximab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      8/45 (17.78%)      12/45 (26.67%)    
Blood and lymphatic system disorders       
Febrile neutropenia † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Hemoglobin decreased † 1  0/0  0 4/45 (8.89%)  4 4/45 (8.89%)  4
Cardiac disorders       
Sinus arrhythmia † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  2
Sinus tachycardia † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Endocrine disorders       
Hypothyroidism † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Eye disorders       
Dry eye syndrome † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  4
Vision blurred † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Gastrointestinal disorders       
Abdominal distension † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Abdominal pain † 1  0/0  0 0/45 (0.00%)  0 2/45 (4.44%)  2
Colitis † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Constipation † 1  0/0  0 1/45 (2.22%)  2 4/45 (8.89%)  8
Diarrhea † 1  0/0  0 0/45 (0.00%)  0 2/45 (4.44%)  2
Dyspepsia † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Dysphagia † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Ear, nose and throat examination abnormal † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Esophageal pain † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Hemorrhoids † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Nausea † 1  0/0  0 2/45 (4.44%)  2 3/45 (6.67%)  3
Obstruction gastric † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Oral pain † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Vomiting † 1  0/0  0 1/45 (2.22%)  1 2/45 (4.44%)  2
General disorders       
Chest pain † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Chills † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Death NOS † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Disease progression † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Edema limbs † 1  0/0  0 1/45 (2.22%)  1 2/45 (4.44%)  2
Fatigue † 1  0/0  0 5/45 (11.11%)  6 7/45 (15.56%)  11
Fever † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Gait abnormal † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Pain † 1  0/0  0 2/45 (4.44%)  2 0/45 (0.00%)  0
Immune system disorders       
Cytokine release syndrome † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Infections and infestations       
Bronchitis † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Infection † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Opportunistic infection † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Pneumonia † 1  0/0  0 2/45 (4.44%)  2 2/45 (4.44%)  2
Sepsis † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Skin infection † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Vaginal infection † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Injury, poisoning and procedural complications       
Intraoperative musculoskeletal injury † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Investigations       
Alanine aminotransferase increased † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  2
Alkaline phosphatase increased † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Aspartate aminotransferase increased † 1  0/0  0 1/45 (2.22%)  1 2/45 (4.44%)  3
Blood bilirubin increased † 1  0/0  0 1/45 (2.22%)  1 3/45 (6.67%)  4
Creatinine increased † 1  0/0  0 1/45 (2.22%)  1 3/45 (6.67%)  4
Electrocardiogram QTc interval prolonged † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
INR increased † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Leukocyte count decreased † 1  0/0  0 4/45 (8.89%)  4 5/45 (11.11%)  6
Lymphocyte count decreased † 1  0/0  0 2/45 (4.44%)  2 3/45 (6.67%)  3
Neutrophil count decreased † 1  0/0  0 2/45 (4.44%)  2 4/45 (8.89%)  6
Platelet count decreased † 1  0/0  0 6/45 (13.33%)  7 5/45 (11.11%)  6
Weight loss † 1  0/0  0 2/45 (4.44%)  2 0/45 (0.00%)  0
Metabolism and nutrition disorders       
Alkalosis † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Anorexia † 1  0/0  0 2/45 (4.44%)  2 0/45 (0.00%)  0
Blood glucose increased † 1  0/0  0 4/45 (8.89%)  4 6/45 (13.33%)  7
Dehydration † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Serum albumin decreased † 1  0/0  0 0/45 (0.00%)  0 5/45 (11.11%)  5
Serum calcium decreased † 1  0/0  0 2/45 (4.44%)  2 4/45 (8.89%)  4
Serum glucose decreased † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Serum magnesium increased † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Serum phosphate decreased † 1  0/0  0 0/45 (0.00%)  0 2/45 (4.44%)  2
Serum potassium decreased † 1  0/0  0 0/45 (0.00%)  0 2/45 (4.44%)  2
Serum sodium decreased † 1  0/0  0 1/45 (2.22%)  1 5/45 (11.11%)  5
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  0/0  0 0/45 (0.00%)  0 2/45 (4.44%)  2
Back pain † 1  0/0  0 2/45 (4.44%)  2 1/45 (2.22%)  1
Bone pain † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Muscle weakness lower limb † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Myalgia † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Neck pain † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Pain in extremity † 1  0/0  0 1/45 (2.22%)  1 2/45 (4.44%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumor flare † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Nervous system disorders       
Dysgeusia † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Ischemia cerebrovascular † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Mini mental status examination abnormal † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Neuralgia † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Peripheral sensory neuropathy † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Seizure † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Speech disorder † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Psychiatric disorders       
Depression † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Insomnia † 1  0/0  0 0/45 (0.00%)  0 2/45 (4.44%)  2
Renal and urinary disorders       
Kidney pain † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Proteinuria † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Renal failure † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Ureteric obstruction † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Allergic rhinitis † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Bronchospasm † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Cough † 1  0/0  0 2/45 (4.44%)  3 4/45 (8.89%)  4
Dyspnea † 1  0/0  0 3/45 (6.67%)  5 4/45 (8.89%)  4
Hypoxia † 1  0/0  0 2/45 (4.44%)  2 0/45 (0.00%)  0
Pleural effusion † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dry skin † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  5
Erythema multiforme † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Pruritus † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Sweating † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Vascular disorders       
Flushing † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Hot flashes † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Hypotension † 1  0/0  0 2/45 (4.44%)  2 1/45 (2.22%)  1
Thrombosis † 1  0/0  0 3/45 (6.67%)  3 2/45 (4.44%)  2
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I - Rituximab Arm II - Lenalidomide Arm III - Lenalidomide and Rituximab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      44/45 (97.78%)      41/45 (91.11%)    
Blood and lymphatic system disorders       
Febrile neutropenia † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Hemoglobin decreased † 1  0/0  0 19/45 (42.22%)  89 17/45 (37.78%)  86
Lymph node pain † 1  0/0  0 1/45 (2.22%)  2 0/45 (0.00%)  0
Cardiac disorders       
Cardiac disorder † 1  0/0  0 0/45 (0.00%)  0 2/45 (4.44%)  2
Cardiac pain † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Left ventricular dysfunction † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Sinus bradycardia † 1  0/0  0 0/45 (0.00%)  0 2/45 (4.44%)  3
Ventricular arrhythmia † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Ear and labyrinth disorders       
Ear pain † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
External ear pain † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  2
Hearing impaired † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Endocrine disorders       
Hypothyroidism † 1  0/0  0 1/45 (2.22%)  1 6/45 (13.33%)  24
Eye disorders       
Dry eye syndrome † 1  0/0  0 3/45 (6.67%)  5 2/45 (4.44%)  3
Eye disorder † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Glaucoma † 1  0/0  0 1/45 (2.22%)  3 0/45 (0.00%)  0
Watering eyes † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  3
Gastrointestinal disorders       
Abdominal distension † 1  0/0  0 2/45 (4.44%)  2 2/45 (4.44%)  7
Abdominal pain † 1  0/0  0 3/45 (6.67%)  6 4/45 (8.89%)  9
Anal hemorrhage † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Constipation † 1  0/0  0 21/45 (46.67%)  40 16/45 (35.56%)  45
Diarrhea † 1  0/0  0 14/45 (31.11%)  46 14/45 (31.11%)  34
Dry mouth † 1  0/0  0 3/45 (6.67%)  12 4/45 (8.89%)  6
Dyspepsia † 1  0/0  0 6/45 (13.33%)  7 2/45 (4.44%)  4
Ear, nose and throat examination abnormal † 1  0/0  0 2/45 (4.44%)  2 1/45 (2.22%)  3
Esophageal pain † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Esophagitis † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Gastrointestinal disorder † 1  0/0  0 2/45 (4.44%)  4 0/45 (0.00%)  0
Gastroscopy abnormal † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Hemorrhoids † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Nausea † 1  0/0  0 16/45 (35.56%)  40 12/45 (26.67%)  32
Oral pain † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Rectal hemorrhage † 1  0/0  0 1/45 (2.22%)  2 0/45 (0.00%)  0
Stomach pain † 1  0/0  0 1/45 (2.22%)  3 0/45 (0.00%)  0
Toothache † 1  0/0  0 1/45 (2.22%)  1 2/45 (4.44%)  3
Vomiting † 1  0/0  0 4/45 (8.89%)  9 6/45 (13.33%)  7
General disorders       
Chest pain † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  7
Chills † 1  0/0  0 2/45 (4.44%)  2 7/45 (15.56%)  7
Edema limbs † 1  0/0  0 9/45 (20.00%)  28 6/45 (13.33%)  11
Fatigue † 1  0/0  0 35/45 (77.78%)  138 33/45 (73.33%)  166
Fever † 1  0/0  0 2/45 (4.44%)  2 7/45 (15.56%)  7
Flu-like symptoms † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
General symptom † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Localized edema † 1  0/0  0 2/45 (4.44%)  3 0/45 (0.00%)  0
Pain † 1  0/0  0 4/45 (8.89%)  5 4/45 (8.89%)  16
Hepatobiliary disorders       
Gallbladder pain † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Immune system disorders       
Cytokine release syndrome † 1  0/0  0 1/45 (2.22%)  1 12/45 (26.67%)  12
Hypersensitivity † 1  0/0  0 3/45 (6.67%)  4 3/45 (6.67%)  3
Immune system disorder † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Infections and infestations       
Bronchitis † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Catheter related infection † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Gastric infection † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Gingival infection † 1  0/0  0 0/45 (0.00%)  0 2/45 (4.44%)  3
Infection † 1  0/0  0 2/45 (4.44%)  2 2/45 (4.44%)  2
Otitis media † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Pharyngitis † 1  0/0  0 0/45 (0.00%)  0 2/45 (4.44%)  2
Rhinitis infective † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Sinusitis † 1  0/0  0 3/45 (6.67%)  3 8/45 (17.78%)  15
Skin infection † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Tooth infection † 1  0/0  0 2/45 (4.44%)  2 0/45 (0.00%)  0
Tracheitis † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Upper respiratory infection † 1  0/0  0 5/45 (11.11%)  7 2/45 (4.44%)  3
Urinary tract infection † 1  0/0  0 0/45 (0.00%)  0 3/45 (6.67%)  11
Vaginal infection † 1  0/0  0 1/45 (2.22%)  2 1/45 (2.22%)  2
Injury, poisoning and procedural complications       
Bruising † 1  0/0  0 1/45 (2.22%)  5 1/45 (2.22%)  1
Thermal burn † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Vascular access complication † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Investigations       
Alanine aminotransferase increased † 1  0/0  0 8/45 (17.78%)  27 9/45 (20.00%)  35
Alkaline phosphatase increased † 1  0/0  0 5/45 (11.11%)  14 2/45 (4.44%)  4
Aspartate aminotransferase increased † 1  0/0  0 8/45 (17.78%)  21 10/45 (22.22%)  33
Blood bilirubin increased † 1  0/0  0 2/45 (4.44%)  6 8/45 (17.78%)  31
Creatinine increased † 1  0/0  0 6/45 (13.33%)  10 4/45 (8.89%)  14
INR increased † 1  0/0  0 2/45 (4.44%)  2 0/45 (0.00%)  0
Laboratory test abnormal † 1  0/0  0 1/45 (2.22%)  3 2/45 (4.44%)  15
Leukocyte count decreased † 1  0/0  0 21/45 (46.67%)  86 16/45 (35.56%)  131
Lymphocyte count decreased † 1  0/0  0 9/45 (20.00%)  21 13/45 (28.89%)  80
Neutrophil count decreased † 1  0/0  0 19/45 (42.22%)  94 25/45 (55.56%)  123
Platelet count decreased † 1  0/0  0 25/45 (55.56%)  96 23/45 (51.11%)  114
Serum cholesterol increased † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Weight gain † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Weight loss † 1  0/0  0 2/45 (4.44%)  2 3/45 (6.67%)  4
Metabolism and nutrition disorders       
Anorexia † 1  0/0  0 6/45 (13.33%)  12 5/45 (11.11%)  8
Blood glucose increased † 1  0/0  0 15/45 (33.33%)  50 14/45 (31.11%)  55
Blood uric acid increased † 1  0/0  0 3/45 (6.67%)  5 2/45 (4.44%)  2
Glucose intolerance † 1  0/0  0 1/45 (2.22%)  4 0/45 (0.00%)  0
Serum albumin decreased † 1  0/0  0 7/45 (15.56%)  12 6/45 (13.33%)  18
Serum calcium decreased † 1  0/0  0 8/45 (17.78%)  24 10/45 (22.22%)  38
Serum calcium increased † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  11
Serum glucose decreased † 1  0/0  0 4/45 (8.89%)  6 7/45 (15.56%)  14
Serum magnesium decreased † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Serum phosphate decreased † 1  0/0  0 6/45 (13.33%)  10 6/45 (13.33%)  23
Serum potassium decreased † 1  0/0  0 7/45 (15.56%)  13 6/45 (13.33%)  27
Serum potassium increased † 1  0/0  0 2/45 (4.44%)  3 2/45 (4.44%)  4
Serum sodium decreased † 1  0/0  0 6/45 (13.33%)  20 6/45 (13.33%)  16
Serum sodium increased † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  2
Serum triglycerides increased † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  0/0  0 1/45 (2.22%)  1 7/45 (15.56%)  13
Arthritis † 1  0/0  0 0/45 (0.00%)  0 3/45 (6.67%)  8
Back pain † 1  0/0  0 6/45 (13.33%)  9 6/45 (13.33%)  14
Bone pain † 1  0/0  0 1/45 (2.22%)  5 3/45 (6.67%)  4
Chest wall pain † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Muscle weakness † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  2
Muscle weakness upper limb † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Musculoskeletal disorder † 1  0/0  0 3/45 (6.67%)  5 4/45 (8.89%)  15
Myalgia † 1  0/0  0 7/45 (15.56%)  16 6/45 (13.33%)  20
Myositis † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Neck pain † 1  0/0  0 3/45 (6.67%)  3 0/45 (0.00%)  0
Pain in extremity † 1  0/0  0 4/45 (8.89%)  6 4/45 (8.89%)  9
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumor flare † 1  0/0  0 1/45 (2.22%)  1 2/45 (4.44%)  2
Tumor pain † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Nervous system disorders       
Ataxia † 1  0/0  0 1/45 (2.22%)  4 0/45 (0.00%)  0
Depressed level of consciousness † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  2
Dizziness † 1  0/0  0 8/45 (17.78%)  11 10/45 (22.22%)  16
Dysgeusia † 1  0/0  0 5/45 (11.11%)  18 3/45 (6.67%)  7
Headache † 1  0/0  0 5/45 (11.11%)  16 5/45 (11.11%)  10
Memory impairment † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Neuralgia † 1  0/0  0 1/45 (2.22%)  3 0/45 (0.00%)  0
Neurological disorder NOS † 1  0/0  0 1/45 (2.22%)  2 1/45 (2.22%)  1
Olfactory nerve disorder † 1  0/0  0 1/45 (2.22%)  4 0/45 (0.00%)  0
Peripheral motor neuropathy † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  2
Peripheral sensory neuropathy † 1  0/0  0 15/45 (33.33%)  32 17/45 (37.78%)  51
Syncope † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Tremor † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  4
Trigeminal nerve disorder † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Psychiatric disorders       
Anxiety † 1  0/0  0 1/45 (2.22%)  1 2/45 (4.44%)  2
Depression † 1  0/0  0 4/45 (8.89%)  15 1/45 (2.22%)  2
Insomnia † 1  0/0  0 4/45 (8.89%)  6 4/45 (8.89%)  10
Libido decreased † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Renal and urinary disorders       
Bladder spasm † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Proteinuria † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  1
Urinary frequency † 1  0/0  0 2/45 (4.44%)  2 3/45 (6.67%)  4
Urinary incontinence † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Urinary retention † 1  0/0  0 1/45 (2.22%)  1 2/45 (4.44%)  7
Reproductive system and breast disorders       
Pelvic pain † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  5
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis † 1  0/0  0 9/45 (20.00%)  20 6/45 (13.33%)  12
Bronchospasm † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Cough † 1  0/0  0 8/45 (17.78%)  15 11/45 (24.44%)  30
Dyspnea † 1  0/0  0 6/45 (13.33%)  13 8/45 (17.78%)  14
Nasal congestion † 1  0/0  0 1/45 (2.22%)  2 1/45 (2.22%)  1
Pharyngolaryngeal pain † 1  0/0  0 2/45 (4.44%)  3 4/45 (8.89%)  6
Pleural effusion † 1  0/0  0 1/45 (2.22%)  2 0/45 (0.00%)  0
Pneumonitis † 1  0/0  0 0/45 (0.00%)  0 1/45 (2.22%)  7
Pulmonary hemorrhage † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Respiratory disorder † 1  0/0  0 4/45 (8.89%)  4 6/45 (13.33%)  8
Skin and subcutaneous tissue disorders       
Alopecia † 1  0/0  0 1/45 (2.22%)  3 0/45 (0.00%)  0
Dry skin † 1  0/0  0 7/45 (15.56%)  12 2/45 (4.44%)  2
Erythema multiforme † 1  0/0  0 10/45 (22.22%)  15 8/45 (17.78%)  22
Petechiae † 1  0/0  0 2/45 (4.44%)  2 0/45 (0.00%)  0
Pruritus † 1  0/0  0 9/45 (20.00%)  17 6/45 (13.33%)  16
Rash acneiform † 1  0/0  0 1/45 (2.22%)  1 1/45 (2.22%)  1
Rash desquamating † 1  0/0  0 11/45 (24.44%)  16 10/45 (22.22%)  13
Skin disorder † 1  0/0  0 6/45 (13.33%)  9 8/45 (17.78%)  11
Skin hypopigmentation † 1  0/0  0 1/45 (2.22%)  5 0/45 (0.00%)  0
Skin ulceration † 1  0/0  0 1/45 (2.22%)  1 0/45 (0.00%)  0
Sweating † 1  0/0  0 6/45 (13.33%)  8 3/45 (6.67%)  4
Vascular disorders       
Hot flashes † 1  0/0  0 1/45 (2.22%)  8 0/45 (0.00%)  0
Hypotension † 1  0/0  0 3/45 (6.67%)  5 0/45 (0.00%)  0
Peripheral ischemia † 1  0/0  0 1/45 (2.22%)  2 0/45 (0.00%)  0
Thrombosis † 1  0/0  0 4/45 (8.89%)  7 1/45 (2.22%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: John P Leonard, M.D.
Organization: Meyer Cancer Center, Weill Cornell Medical College
EMail: jpleonar@med.cornell.edu
Publications of Results:
Leonard JP, Jung SH, Johnson J, Pitcher BN, Bartlett NL, Blum KA, Czuczman M, Giguere JK, Cheson BD. Randomized Trial of Lenalidomide Alone Versus Lenalidomide Plus Rituximab in Patients With Recurrent Follicular Lymphoma: CALGB 50401 (Alliance). J Clin Oncol. 2015 Nov 1;33(31):3635-40. doi: 10.1200/JCO.2014.59.9258. Epub 2015 Aug 24.
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00238238    
Other Study ID Numbers: CALGB-50401
CALGB-50401
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000442872 ( Registry Identifier: NCI Physician Data Query )
First Submitted: October 12, 2005
First Posted: October 13, 2005
Results First Submitted: December 15, 2016
Results First Posted: February 7, 2017
Last Update Posted: March 15, 2017