Study Role of Lenalidomide in Improving Sleep in CLL Patients 65+ Years Experiencing Clinically Significant Fatigue - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00792077

Purpose

Objective:

A. To determine the change in total sleep time as measured by polysomnography(PSG) in Chronic lymphocytic leukemia (CLL) patients with fatigue of > or = 4(on a 0-10 scale) on the MD Anderson symptom inventory (MDASI) before and after the 1st cycle of treatment (day 57 +/- 3 days) with lenalidomide,

B.1. To summarize variables associated with sleep architecture as measured by PSG before and after the 1st cycle of treatment (57 days +/- 3 days) with lenalidomide, in this population,

B.2. To summarize the variables associated with PSQI, Epworth sleep scale, actigraphy in relation to sleep and FACIT-F in relation to fatigue before and after treatment (57 days +/- 3 days) with lenalidomide.

B.3. To determine the relationship between changes in inflammatory cytokines levels and the frequency and intensity of fatigue and sleep disturbances in these patients as measured by the MDASI before and after the 1st cycle of treatment (57 days +/- 3 days) with lenalidomide.

Condition	Intervention
Leukemia CLL	Drug: Lenalidomide

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	A Pilot Open Label Study to Investigate the Role of Lenalidomide in Improving Cancer Related Sleep in CLL Patients Over 65 Years of Age Experiencing Clinically Significant Fatigue

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To study if lenalidomide can help to control symptoms such as sleep problems and fatigue in patients with chronic lymphocytic leukemia (CLL). [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	November 2008
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lenalidomide + Actigraph + Questionnaire + Sleep Test	Drug: Lenalidomide 5 mg daily for 56 days.

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Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Patients to be 65 yrs or older.
Describe fatigue as being present every day for most of day for a minimum of 2 weeks and rate fatigue greater than or equal to 4 on a 0-10 scale, in which 0= no fatigue and 10=worst possible fatigue as assessed by MD Anderson symptom Inventory(MDASI).
Have to be enrolled in a clinical trial of lenalidomide to treat CLL[2006-0715, 2007-0213]
Patients will be eligible to participate in this study if they rate sleep disturbance greater than or equal to 4 on a 0-10 scale, in which 0= disturbed sleep is not present and 10 = disturbed sleep as bad as you can imagine as assessed by MDASI.
Have a MDAS of 13 or less.
Able to understand the description of the study and give written informed consent.

Exclusion:

Patients who are unable to complete the assessment measures or refuse to participate
Patients with known history of brain metastasis.
Patients with known history of sleep apnea.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792077

Contacts

Contact: Sriram Yennurajalingam, MD

713-792-6085

Locations

United States, Texas
The University of Texas M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Sriram Yennurajalingam, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Sriram Yennurajalingam, MD

M.D. Anderson Cancer Center

More Information

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D Anderson Cancer Center ( Sriram Yennurajalingam, MD/Assistant Professor )
Study ID Numbers:	2007-0945
Study First Received:	November 13, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00792077
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Leukemia
Lenalidomide
Actigraph
Sleep Test Study

Chronic Lymphocytic Leukemia
CC-5013
Revlimid

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Leukemia
Leukemia, Lymphoid
Fatigue

Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, chronic
Lenalidomide

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009