Trial Outcomes & Findings for A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (NCT NCT00474188)
NCT ID: NCT00474188
Last Updated: 2009-09-02
Results Overview
Number of participants demonstrating complete or partial tumor response (Cheson B, Horning S, Coiffier B, Shipp M, Fisher R, Connors J, et al, Report of an international workshop to standardize response criteria for non-Hodgkins' lymphoma. J Clin Oncol.1999;17:1244-53). Study terminated prematurely. Analysis not conducted.
TERMINATED
PHASE2
26 participants
One Year
2009-09-02
Participant Flow
Participant milestones
| Measure |
Lenalidomide in Combination With Dexamethasone
Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Lenalidomide in Combination With Dexamethasone
Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Study discontinued by sponsor
|
5
|
Baseline Characteristics
A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Lenalidomide in Combination With Dexamethasone
n=26 Participants
Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Age Continuous
|
66.7 years
STANDARD_DEVIATION 11.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One YearPopulation: Study terminated prematurely. Analyses of efficacy not conducted.
Number of participants demonstrating complete or partial tumor response (Cheson B, Horning S, Coiffier B, Shipp M, Fisher R, Connors J, et al, Report of an international workshop to standardize response criteria for non-Hodgkins' lymphoma. J Clin Oncol.1999;17:1244-53). Study terminated prematurely. Analysis not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One YearNumber of participants demonstrating complete tumor response, partial tumor response, or stable disease. Study terminated prematurely. Analysis not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One yearTime from first demonstration of at least a partial response to the first documentation of disease progression, including death due to non-Hodgkin's lymphoma. Study terminated prematurely. Analysis not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One yearTime from the start of study drug therapy to the first documentation of disease progression. Study terminated prematurely. Analysis not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One yearTime from the start of study drug therapy to the first observation of disease progression or death due to any cause. Study terminated prematurely. Analysis not conducted.
Outcome measures
Outcome data not reported
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator shall have the right to publish and/or present the data generated from the study provided that the investigator shall (i) furnish the sponsor with a copy of any proposed publication or presentation at least thirty (30) days in advance of the submission of such material, (ii) delete from such material any confidential information of the sponsor, and (iii) delay submission of same for up to sixty (60) days to permit the preparation and filing of intellectual property applications.
- Publication restrictions are in place
Restriction type: OTHER