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Trial record 54 of 495 for:    LENALIDOMIDE AND every 28 days

Lenalidomide (Revlimid®) as Second Line Therapy in Patients With Chronic Graft-Vs-Host Disease (GVHD)

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ClinicalTrials.gov Identifier: NCT00675441
Recruitment Status : Terminated (Terminated due to slow accrual.)
First Posted : May 9, 2008
Results First Posted : December 11, 2013
Last Update Posted : December 11, 2013
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
Condition Graft-versus-Host Disease
Intervention Drug: Lenalidomide
Enrollment 5
Recruitment Details Recruitment Period: 04/16/2008 to 12/01/2010. All participants were recruited at The University of Texas MD Anderson Cancer Center medical clinics.
Pre-assignment Details  
Arm/Group Title Lenalidomide
Hide Arm/Group Description Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
Period Title: Overall Study
Started 5
Completed 2
Not Completed 3
Reason Not Completed
Withdrawal by Subject             2
Death             1
Arm/Group Title Lenalidomide
Hide Arm/Group Description Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
55
(35 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Number of Participants' With Treatment Response of Complete or Partial Response
Hide Description Treatment responses defined as complete (CR) or partial organ response (PR) of chronic Graft-Versus-Host Disease (GVHD) to lenalidomide. Complete organ response (CR) indicates resolution of all reversible manifestations related to chronic GVHD in a specific organ. Partial organ response (PR) requires at least 50% improvement in scale used to measure disease manifestations related to chronic GVHD. Tools for response evaluation were skin assessment and functional assessment including minute walk and grip strength.
Time Frame Response assessed after completing 28 day cycle, repeated with each cycle for 6 cycles, approximately 180 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Of the five (5) participants enrolled, two participants were taken off study after only a few days of therapy and one participant expired, all three of which were not evaluable for response.
Arm/Group Title Lenalidomide
Hide Arm/Group Description:
Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
2
Time Frame 13 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide
Hide Arm/Group Description Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
All-Cause Mortality
Lenalidomide
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide
Affected / at Risk (%)
Total   1/5 (20.00%) 
Cardiac disorders   
Sudden Cardiac Arrest  1  1/5 (20.00%) 
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 (%)
Total   0/5 (0.00%) 
The study did not meet all primary and secondary objectives due to slow patient accrual.
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: Amin Alousi, MD / Assisstant Professor
Organization: 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: NCT00675441     History of Changes
Other Study ID Numbers: 2006-0321
First Submitted: May 7, 2008
First Posted: May 9, 2008
Results First Submitted: October 21, 2013
Results First Posted: December 11, 2013
Last Update Posted: December 11, 2013