Lenalidomide (Revlimid) in Chronic Lymphocytic Leukemia (CLL)

This study has been completed.

Study NCT00267059 Information provided by M.D. Anderson Cancer Center

First Received on December 19, 2005. Last Updated on March 21, 2011 History of Changes

Results First Received: September 24, 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
Conditions:	Chronic Lymphocytic Leukemia Leukemia
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
Recruitment Period 12/7/05 - 8/7/09; all patients were registered at The University of Texas M.D. Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Forty five patients were registered on this study. Forty four were evaluable. One patient never received treatment.

Reporting Groups

	Description
Lenalidomide	10 mg/day, orally once a day for 28 days

Participant Flow: Overall Study

	Lenalidomide
STARTED	44
COMPLETED	44
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Lenalidomide	10 mg/day, orally once a day for 28 days

Baseline Measures

	Lenalidomide
Number of Participants [units: participants]	44
Age [units: participants]
<=18 years	0
Between 18 and 65 years	25
>=65 years	19
Age [units: years] Median ( Full Range )	63 ( 49 to 86 )
Gender [units: participants]
Female	14
Male	30
Region of Enrollment [units: participants]
United States	44

Outcome Measures

1. Primary:

Number of Patients in Overall Response Categories [ Time Frame: Evaluated after three 28-day cycles of lenalidomide. ]

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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:

All Principal Investigators ARE employed by the organization sponsoring the study.

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: Alessandra Ferrajoli, MD, BS / Associate Professor
Organization: The University of Texas M. D. Anderson Cancer Center
phone: 713-792-2063
e-mail: eharriso@mdanderson.org

No publications provided by M.D. Anderson Cancer Center

Publications automatically indexed to this study:

Ferrajoli A, Lee BN, Schlette EJ, O'Brien SM, Gao H, Wen S, Wierda WG, Estrov Z, Faderl SH, Cohen EN, Li C, Reuben JM, Keating MJ. Lenalidomide induces complete and partial remissions in patients with relapsed and refractory chronic lymphocytic leukemia. Blood. 2008 Mar 11; [Epub ahead of print]

Responsible Party:	Alessandra Ferrajoli, MD, BS / Associate Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00267059 History of Changes
Other Study ID Numbers:	2005-0175
Study First Received:	December 19, 2005
Results First Received:	September 24, 2009
Last Updated:	March 21, 2011
Health Authority:	United States: Food and Drug Administration