Trial Outcomes & Findings for Lenalidomide (Revlimid®) as Second Line Therapy in Patients With Chronic Graft-Vs-Host Disease (GVHD) (NCT NCT00675441)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Response assessed after completing 28 day cycle, repeated with each cycle for 6 cycles, approximately 180 days.

Results posted on

2013-12-11

Participant Flow

Recruitment Period: 04/16/2008 to 12/01/2010. All participants were recruited at The University of Texas MD Anderson Cancer Center medical clinics.

Participant milestones

Participant milestones
Measure	Lenalidomide Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
Overall Study STARTED	5
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Lenalidomide Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
Overall Study Withdrawal by Subject	2
Overall Study Death	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenalidomide n=5 Participants Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
Age Continuous	55 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Response assessed after completing 28 day cycle, repeated with each cycle for 6 cycles, approximately 180 days.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Lenalidomide n=2 Participants Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
Number of Participants' With Treatment Response of Complete or Partial Response	2 participants

Adverse Events

Lenalidomide

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lenalidomide n=5 participants at risk Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
Cardiac disorders Sudden Cardiac Arrest	20.0% 1/5 • 13 months

Other adverse events

Adverse event data not reported

Additional Information

Amin Alousi, MD / Assisstant Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place