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A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00474188
Recruitment Status : Terminated (Business decision)
First Posted : May 16, 2007
Results First Posted : August 13, 2009
Last Update Posted : September 2, 2009
Sponsor:
Information provided by:
Celgene

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diffuse Large B-cell Lymphoma
Interventions Drug: CC-5013 (lenalidomide)
Drug: dexamethasone
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide in Combination With Dexamethasone
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 26
Completed 20 [1]
Not Completed 6
Reason Not Completed
Withdrawal by Subject             1
Study discontinued by sponsor             5
[1]
Disease progression=15, adverse event=4, death=1
Arm/Group Title Lenalidomide in Combination With Dexamethasone
Hide Arm/Group Description 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 Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  38.5%
>=65 years
16
  61.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
66.7  (11.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
10
  38.5%
Male
16
  61.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
Australia 4
Canada 2
United States 20
1.Primary Outcome
Title Tumor Response Rate
Hide Description

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.

Time Frame One Year
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated prematurely. Analyses of efficacy not conducted.
Arm/Group Title Lenalidomide in Combination With Dexamethasone
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Tumor Control Rate
Hide Description

Number of participants demonstrating complete tumor response, partial tumor response, or stable disease.

Study terminated prematurely. Analysis not conducted.

Time Frame One Year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide in Combination With Dexamethasone
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Duration of Response
Hide Description

Time 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.

Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide in Combination With Dexamethasone
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Time to Progression
Hide Description

Time from the start of study drug therapy to the first documentation of disease progression.

Study terminated prematurely. Analysis not conducted.

Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide in Combination With Dexamethasone
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Progression-free Survival
Hide Description

Time 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.

Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide in Combination With Dexamethasone
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Study terminated prematurely as a business decision. Analyses of efficacy not conducted.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Kinght, M.D.
Organization: Celgene Corporation
Phone: 908-673-9749
EMail: rknight@celgene.com
Layout table for additonal information
Responsible Party: Robert Knight, M.D., Celgene/sponsor
ClinicalTrials.gov Identifier: NCT00474188     History of Changes
Other Study ID Numbers: CC-5013-NHL-005
First Submitted: May 14, 2007
First Posted: May 16, 2007
Results First Submitted: June 30, 2009
Results First Posted: August 13, 2009
Last Update Posted: September 2, 2009