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Trial record 14 of 794 for:    LENALIDOMIDE AND cells

Lenalidomide Plus Rituxan for Untreated Mantle Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01472562
Recruitment Status : Active, not recruiting
First Posted : November 16, 2011
Results First Posted : April 7, 2017
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mantle Cell Lymphoma
Interventions Drug: lenalidomide
Biological: rituximab
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description Study Treatment Arm
Period Title: Induction Phase (Week 1- 48)
Started 38
Completed 27
Not Completed 11
Period Title: Maintenance Phase (Week 49 to PD)
Started 27
Completed 4
Not Completed 23
Arm/Group Title All Patients
Hide Arm/Group Description Study Treatment Arm
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 38 participants
65
(42 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
11
  28.9%
Male
27
  71.1%
1.Primary Outcome
Title Overall Response Rate
Hide Description The primary endpoint of overall response rate will be estimated and a 95% confidence interval will be estimated via binomial proportions.
Time Frame 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
Study Treatment Arm
Overall Number of Participants Analyzed 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
92
(78 to 98)
2.Secondary Outcome
Title 2-year Progression-free Survival
Hide Description PFS will be defined as the time from first treatment day until objective or symptomatic progression or death.
Time Frame 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
Study Treatment Arm
Overall Number of Participants Analyzed 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
85
(67 to 94)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description Study Treatment Arm
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%) # Events
Total   11/38 (28.95%)    
Blood and lymphatic system disorders   
Tumor Flare   2/38 (5.26%)  2
Blood Bilirubin Increase   1/38 (2.63%)  1
Cardiac disorders   
Ventricular Fibrillation   1/38 (2.63%)  1
Gastrointestinal disorders   
Cholangitis   1/38 (2.63%)  1
General disorders   
Fever   1/38 (2.63%)  1
Pneumonia   2/38 (5.26%)  2
Shortness of Breath   1/38 (2.63%)  1
Hepatobiliary disorders   
Cholecystitis   1/38 (2.63%)  1
Injury, poisoning and procedural complications   
Hip Fracture   1/38 (2.63%)  1
Infusion Reaction   1/38 (2.63%)  1
Skin and subcutaneous tissue disorders   
Basal Cell Carcinoma   1/38 (2.63%)  1
Melanoma   1/38 (2.63%)  1
Merkel Cell Carcinoma   1/38 (2.63%)  1
Pruritic Rash   1/38 (2.63%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%) # Events
Total   31/38 (81.58%)    
Blood and lymphatic system disorders   
Thrombocytopenia   15/38 (39.47%) 
Leukopenia   23/38 (60.53%) 
Neutropenia   28/38 (73.68%) 
Blood Bilirubin Increased   9/38 (23.68%) 
Anemia   23/38 (60.53%) 
Neutropenic Fever   2/38 (5.26%) 
Tumor Flare   13/38 (34.21%) 
Cardiac disorders   
Hypertension   6/38 (15.79%) 
Endocrine disorders   
Hypothyroidism   6/38 (15.79%) 
Hyperthyroidism   3/38 (7.89%) 
Gastrointestinal disorders   
Constipation   17/38 (44.74%) 
Diarrhea   21/38 (55.26%) 
General disorders   
Nausea   12/38 (31.58%) 
Vomit   5/38 (13.16%) 
Fever   22/38 (57.89%) 
Fatigue   28/38 (73.68%) 
Night Sweats   9/38 (23.68%) 
Dyspnea   11/38 (28.95%) 
Sore Throat   9/38 (23.68%) 
Cough   21/38 (55.26%) 
Abdominal Pain   9/38 (23.68%) 
Head Pain/Headache/Migraine   10/38 (26.32%) 
Rigors   4/38 (10.53%) 
Edema   16/38 (42.11%) 
Chills   5/38 (13.16%) 
Serum Sickness   3/38 (7.89%) 
Hepatobiliary disorders   
Elevated Alanine Aminotransferase   13/38 (34.21%) 
Elevated Aspartate Aminotransferase   11/38 (28.95%) 
Elevated Alkaline Phosphatase   9/38 (23.68%) 
Metabolism and nutrition disorders   
Anorexia   11/38 (28.95%) 
Hypoalbuminemia   13/38 (34.21%) 
Hyperalbuminemia   13/38 (34.21%) 
Hypocalcemia   17/38 (44.74%) 
Hyponatremia   12/38 (31.58%) 
Hypomagnesemia   9/38 (23.68%) 
Hyperkalemia   3/38 (7.89%) 
Hypoglycemia   13/38 (34.21%) 
Hyperglycemia   19/38 (50.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia   10/38 (26.32%) 
Myalgia   7/38 (18.42%) 
Cramping   6/38 (15.79%) 
Gout Flares   4/38 (10.53%) 
Nervous system disorders   
Dysgeusia   7/38 (18.42%) 
Dizziness   8/38 (21.05%) 
Neuropathy   6/38 (15.79%) 
Tinnitus   5/38 (13.16%) 
Product Issues   
Infusion Related Reaction   13/38 (34.21%) 
Renal and urinary disorders   
Urinary tract Infection   7/38 (18.42%) 
Elevated Creatinine   8/38 (21.05%) 
Respiratory, thoracic and mediastinal disorders   
Upper Respiratory Infection   15/38 (39.47%) 
Pneumonia   3/38 (7.89%) 
Bronchial Infection/ Lung Infection   5/38 (13.16%) 
Skin and subcutaneous tissue disorders   
Nasal Congestion   12/38 (31.58%) 
Macro Papular   25/38 (65.79%) 
Indicates events were collected by systematic assessment
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: Jia Ruan M.D, Ph.D
Organization: Weill Cornell Medicine
Phone: 646.962.2064
EMail: amr2017@med.cornell.edu
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01472562     History of Changes
Other Study ID Numbers: 1103011566
First Submitted: March 24, 2011
First Posted: November 16, 2011
Results First Submitted: February 22, 2017
Results First Posted: April 7, 2017
Last Update Posted: February 28, 2019