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

This study has been terminated.

(Business decision)

Sponsor:

Information provided by:

Celgene Corporation

ClinicalTrials.gov Identifier:

NCT00474188

First received: May 14, 2007

Last updated: August 27, 2009

Last verified: August 2009

History of Changes

Results First Received: June 30, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Diffuse Large B-cell Lymphoma
Interventions:	Drug: CC-5013 (lenalidomide) Drug: dexamethasone

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Lenalidomide in Combination With Dexamethasone
STARTED	26
COMPLETED	20 ^[1]
NOT COMPLETED	6
Withdrawal by Subject	1
Study discontinued by sponsor	5

[1]	Disease progression=15, adverse event=4, death=1

Baseline Characteristics

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Reporting Groups

	Description
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.

Baseline Measures

	Lenalidomide in Combination With Dexamethasone
Number of Participants [units: participants]	26
Age [units: participants]
<=18 years	0
Between 18 and 65 years	10
>=65 years	16
Age [units: years] Mean ± Standard Deviation	66.7 ± 11.42
Gender [units: participants]
Female	10
Male	16
Region of Enrollment [units: participants]
Australia	4
Canada	2
United States	20

Outcome Measures

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1. Primary:

Tumor Response Rate [ Time Frame: One Year ]

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2. Secondary:

Tumor Control Rate [ Time Frame: One Year ]

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3. Secondary:

Duration of Response [ Time Frame: One year ]

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4. Secondary:

Time to Progression [ Time Frame: One year ]

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5. Secondary:

Progression-free Survival [ Time Frame: One year ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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 agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study terminated prematurely as a business decision. Analyses of efficacy not conducted.

Results Point of Contact:

Name/Title: Robert Kinght, M.D.
Organization: Celgene Corporation
phone: 908-673-9749
e-mail: rknight@celgene.com

No publications provided

Responsible Party:	Robert Knight, M.D., Celgene/sponsor
ClinicalTrials.gov Identifier:	NCT00474188 History of Changes
Other Study ID Numbers:	CC-5013-NHL-005
Study First Received:	May 14, 2007
Results First Received:	June 30, 2009
Last Updated:	August 27, 2009
Health Authority:	United States: Food and Drug Administration

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