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Trial record 36 of 179 for:    LENALIDOMIDE AND Leukemia

Lenalidomide (Revlimid) in Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT00267059
Recruitment Status : Completed
First Posted : December 20, 2005
Results First Posted : April 21, 2011
Last Update Posted : August 7, 2012
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Lymphocytic Leukemia
Leukemia
Intervention Drug: Lenalidomide
Enrollment 45
Recruitment Details Recruitment Period 12/7/05 - 8/7/09; all patients were registered at The University of Texas M.D. Anderson Cancer Center.
Pre-assignment Details Forty five patients were registered on this study. Forty four were evaluable. One patient never received treatment.
Arm/Group Title Lenalidomide
Hide Arm/Group Description 10 mg/day, orally once a day for 28 days
Period Title: Overall Study
Started 44
Completed 44
Not Completed 0
Arm/Group Title Lenalidomide
Hide Arm/Group Description 10 mg/day, orally once a day for 28 days
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
  56.8%
>=65 years
19
  43.2%
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants
63
(49 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
14
  31.8%
Male
30
  68.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants
44
1.Primary Outcome
Title Number of Patients in Overall Response Categories
Hide Description Overall Response defined as participant had either complete response (CR) or partial response (PR) assessed after three cycles, at six months and yearly thereafter using the NCI-Working Group Criteria: Complete Response, Complete Response with Nodules, Partial Response, or No Response.
Time Frame Evaluated after three 28-day cycles of lenalidomide.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat (ITT): Forty four patients received treatment.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
10 mg/day, orally once a day for 28 days
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: Participants
Complete Response 3
Complete Response With Nodules 1
Partial Response 10
No Response 30
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide
Hide Arm/Group Description 10 mg/day, orally once a day for 28 days
All-Cause Mortality
Lenalidomide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide
Affected / at Risk (%) # Events
Total   24/44 (54.55%)    
Blood and lymphatic system disorders   
Anemia  1  2/44 (4.55%)  2
Hyperbilirubinemia  1  1/44 (2.27%)  1
Thrombocytopenia  1  1/44 (2.27%)  1
Cardiac disorders   
Hypertension  1  1/44 (2.27%)  1
Hypotension  1  2/44 (4.55%)  2
Stroke  1  1/44 (2.27%)  1
Gastrointestinal disorders   
Mucormycosis  1  1/44 (2.27%)  1
Diarrhea  1  1/44 (2.27%)  1
Rotavirus  1  1/44 (2.27%)  1
Criptosporididosis  1  1/44 (2.27%)  1
General disorders   
Pain  1  3/44 (6.82%)  3
Death  1  1/44 (2.27%)  1
Tumor Flare  1  1/44 (2.27%)  1
Immune system disorders   
Viral Hepatitis Reactivation  1  1/44 (2.27%)  1
Infections and infestations   
Pseudomonas Aeruginosa Bactremia  1  1/44 (2.27%)  1
Infection  1  1/44 (2.27%)  1
Pneumonia  1  8/44 (18.18%)  9
Pneumocystis carinii pneumonia  1  2/44 (4.55%)  2
Fever of unknown origin  1  6/44 (13.64%)  6
Diverticulitis  1  1/44 (2.27%)  1
Prostate Infection  1  1/44 (2.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Secondary Malignancy Lung  1  1/44 (2.27%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion  1  1/44 (2.27%)  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   34/44 (77.27%)    
Blood and lymphatic system disorders   
Neutropenia  1  13/44 (29.55%)  170
Thrombocytopenia  1  14/44 (31.82%)  103
Anemia  1  5/44 (11.36%)  72
Gastrointestinal disorders   
Diarrhea  1  6/44 (13.64%)  50
General disorders   
Fatigue  1  14/44 (31.82%)  75
Tumor Flare  1  15/44 (34.09%)  33
Skin and subcutaneous tissue disorders   
Rash  1  12/44 (27.27%)  43
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, BS / 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: NCT00267059     History of Changes
Other Study ID Numbers: 2005-0175
First Submitted: December 19, 2005
First Posted: December 20, 2005
Results First Submitted: September 24, 2009
Results First Posted: April 21, 2011
Last Update Posted: August 7, 2012