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Trial record 29 of 42 for:    LENALIDOMIDE AND Leukemia AND SLL

Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) Age 65 and Older

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ClinicalTrials.gov Identifier: NCT00535873
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : September 2, 2013
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
Celgene
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 Leukemia
CLL
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Intervention Drug: Lenalidomide
Enrollment 61
Recruitment Details Recruitment Period: 10/3/2007 through 7/10/2009. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details Sixty-one participants were registered and signed consent for this study. One participant signed consent but never received study medication.
Arm/Group Title Lenalidomide
Hide Arm/Group Description Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
Period Title: Overall Study
Started 60
Completed 60
Not Completed 0
Arm/Group Title Lenalidomide
Hide Arm/Group Description Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
One of the sixty-one participants who signed consent did not receive study medication and was not included in the analysis for this study.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants
71
(66 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
26
  43.3%
Male
34
  56.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants
60
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR defined as number of participants with best response of Complete Response (CR) or Partial Response (PR) out of total number of participants. CR is defined as absence of lymphadenopathy, hepatomegaly or splenomegaly on physical exam. Normal Complete Blood Count (CBC) with polymorphonuclear leukocytes >1500/µL, platelets >100,000/µL, hemoglobin >11.0 g/dL (untransfused); lymphocyte count <5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with <30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. PR requires a 50% decrease in peripheral lymphocyte count from , 50% reduction in lymphadenopathy, and/or 50% reduction in splenomegaly/hepatomegaly for a period of at least two months from completion of therapy. These patients must have one of the following: Polymorphonuclear leukocytes 1,500/µL or 50% improvement ; Platelets >100,000/µL or 50% improvement ; Hemoglobin >11.0 g/dL (untransfused) or 50% improvement from pre-treatment value.
Time Frame From 3 cycles (90 days) up to 6 cycles (approximately 180 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
39
Time Frame 5 years 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide
Hide Arm/Group Description Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
All-Cause Mortality
Lenalidomide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide
Affected / at Risk (%) # Events
Total   24/60 (40.00%)    
Blood and lymphatic system disorders   
Abnormal Coagulation tests  1  1/60 (1.67%)  1
Neutropenia  1  2/60 (3.33%)  2
Gastrointestinal disorders   
Anorexia  1  1/60 (1.67%)  1
Constipation  1  1/60 (1.67%)  1
Dehydration  1  1/60 (1.67%)  1
Necrosis  1  1/60 (1.67%)  1
General disorders   
Fatigue  1  3/60 (5.00%)  3
Fever  1  4/60 (6.67%)  4
Pain  1  1/60 (1.67%)  1
Infections and infestations   
Febrile Neutropenia  1  1/60 (1.67%)  1
Pneumonia  1  7/60 (11.67%)  7
Metabolism and nutrition disorders   
Hyperbilirubinemia  1  1/60 (1.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Prostatic Adenocarcinoma  1  1/60 (1.67%)  1
Nervous system disorders   
Cerebrovascular Ischemia  1  1/60 (1.67%)  1
Confusion  1  1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders   
Atelectasis  1  1/60 (1.67%)  1
Dyspnea  1  2/60 (3.33%)  2
Surgical and medical procedures   
Hernia Repair  1  2/60 (3.33%)  2
Hip Replacement Surgery  1  1/60 (1.67%)  1
Vascular disorders   
Embolism  1  1/60 (1.67%)  1
Vessel injury lower extremity  1  1/60 (1.67%)  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
Affected / at Risk (%) # Events
Total   60/60 (100.00%)    
Blood and lymphatic system disorders   
Peripheral Edema  1  6/60 (10.00%)  6
Gastrointestinal disorders   
Diarrhea  1  22/60 (36.67%)  22
Constipation  1  11/60 (18.33%)  11
Nausea  1  10/60 (16.67%)  10
Anorexia  1  9/60 (15.00%)  9
Heartburn  1  6/60 (10.00%)  6
General disorders   
Fatigue  1  32/60 (53.33%)  32
Tumor Flare  1  16/60 (26.67%)  16
GI Pain  1  7/60 (11.67%)  7
Headache  1  6/60 (10.00%)  6
Metabolism and nutrition disorders   
Metabolic Laboratory abnormality  1  9/60 (15.00%)  9
Hyperglycemia  1  8/60 (13.33%)  8
Elevated Serum Creatinine  1  7/60 (11.67%)  7
Hypomagnesemia  1  7/60 (11.67%)  7
Hyperbilirubinemia  1  6/60 (10.00%)  6
Musculoskeletal and connective tissue disorders   
Arthralgia  1  10/60 (16.67%)  10
Nervous system disorders   
Sencory Neuropathy  1  14/60 (23.33%)  14
Neurologic - Other  1  10/60 (16.67%)  10
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  6/60 (10.00%)  6
Skin and subcutaneous tissue disorders   
Rash  1  13/60 (21.67%)  13
Pruritus  1  8/60 (13.33%)  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/Associate Professor
Organization: The University of Texas M D Anderson Cancer Center
Phone: 713-792-2063
EMail: eharriso@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00535873     History of Changes
Other Study ID Numbers: 2006-0715
First Submitted: September 25, 2007
First Posted: September 26, 2007
Results First Submitted: June 19, 2013
Results First Posted: September 2, 2013
Last Update Posted: August 21, 2018