A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Celgene Corporation

ClinicalTrials.gov Identifier:

NCT00413036

First received: December 18, 2006

Last updated: March 6, 2013

Last verified: March 2013

History of Changes

Results First Received: January 9, 2013

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Lymphoma, Non-Hodgkin's
Intervention:	Drug: lenalidomide

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
217 participants were enrolled and received at least one dose of study medication.

Reporting Groups

	Description
Lenalidomide	25 mg oral lenalidomide once daily on Days 1-21 every 28 days

Participant Flow: Overall Study

	Lenalidomide
STARTED	217
COMPLETED	0 ^[1]
NOT COMPLETED	217
Adverse Event	44
Lack of Efficacy	129
Withdrawal by Subject	7
Death	9
Unspecified	26
Missing	2

[1]	Participants remain on study drug until progressive disease or unacceptable adverse events develop.

Baseline Characteristics

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Reporting Groups

	Description
Lenalidomide	25 mg oral lenalidomide once daily on Days 1-21 every 28 days

Baseline Measures

	Lenalidomide
Number of Participants [units: participants]	217
Age [units: years] Mean ± Standard Deviation	65.0 ± 11.54
Age, Customized [units: Participants]
< 65 years	90
> = 65 years	127
Gender [units: participants]
Female	77
Male	140
Race/Ethnicity, Customized [units: Participant]
American Indian or Alaska Native	0
Asian/Pacific Islander	0
Black	4
Hispanic	2
White	202
Unspecified	9
Non-Hodgkin's Lymphoma Diagnosis/Histopathology [units: Participants]
Diffuse Large Cell Lymphoma	108
Follicular Lymphoma, Grade 3	19
Mantle Cell Lymphoma	57
Transformed Lymphoma	33

Outcome Measures

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1. Primary:

Participants Categorized by Best Response as Determined by Central Review [ Time Frame: Up to 1459 days ]

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2. Secondary:

Duration of Response as Determined by Central Review [ Time Frame: Up to 1459 days ]

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3. Secondary:

Time to Progression as Determined by Central Review [ Time Frame: Up to 1459 days ]

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4. Secondary:

Progression-free Survival as Determined by Central Review [ Time Frame: Up to 1459 days ]

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5. Secondary:

Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review [ Time Frame: Up to 1459 days ]

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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: Investigator can publish/present study data after multicenter publication is submitted or 1 yr after study completion. Investigator shall (i) furnish the sponsor a copy of any proposed publication/presentation at least 60 days in advance of the submission, (ii) delete any confidential information of the sponsor, and (iii) delay submission for up to 90 days to permit the preparation and filing of intellectual property applications or until sponsor gives its consent in a timely manner.

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
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Results Point of Contact:

Name/Title: Associate Director, Clinical Trial Disclosure
Organization: Celgene
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00413036 History of Changes
Other Study ID Numbers:	CC-5013-NHL-003
Study First Received:	December 18, 2006
Results First Received:	January 9, 2013
Last Updated:	March 6, 2013
Health Authority:	United States: Food and Drug Administration

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