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Lenalidomide in Chronic Lymphocytic Leukemia (CLL) Patients With Residual Disease
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, December 2008
First Received: March 3, 2008   Last Updated: February 17, 2009   History of Changes
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00632359
  Purpose

The goal of this clinical research study is to learn if Revlimid™ (lenalidomide) can help to reduce the level of leukemia in your body. The safety of this drug will also be studied.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Lenalidomide
Phase II

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, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Study of Lenalidomide in Patients With Chronic Lymphocytic Leukemia and Residual Disease After Chemotherapy - RV-CLL-PI-0270

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

Primary Outcome Measures:
  • To study the ability of lenalidomide to improve the quality of remission (such as from a partial remission to a complete remission). [ Time Frame: August 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To study the ability of lenalidomide to eliminate minimal residual disease as measured by immuno flow cytometry and molecular studies. [ Time Frame: August 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: February 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Lenalidomide
Drug: Lenalidomide
Lenalidomide 10mg daily

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients should have completed their chemotherapy 3 months prior to start of treatment with lenalidomide and not more than 9 months prior to treatment initiation.
  • Patients with CLL/Small Lymphocytic Lymphoma (SLL) that achieve a complete or stable partial remission after combination of chemotherapy. Patients in complete remission need to have documentation of residual disease by immunophenotyping and/or PCR molecular testing.
  • ECOG/WHO status of 0-2.
  • Adequate renal and hepatic function (creatinine equal to or less than 2mg/dL - total bilirubin equal to or less than 2).
  • Females of childbearing potential (FCBP). A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; 2) or has not been naturally postmenopausal for at least 24 consecutive months (has NOT had menses at any time in the preceding 24 consecutive months).
  • FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control; one highly effective and one additional effective method AT THE SAME TIME at least 28 days before starting taking lenalidomide.
  • FCBP must also agree to ongoing pregnancy testing weekly for the first four weeks and then every 28 days while on therapy and at discontinuation of treatment.
  • Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
  • Age 18 and older.
  • Signed, written IRB-approved informed consent.

Exclusion Criteria:

  • Known sensitivity to lenalidomide or thalidomide or it's derivatives
  • Known positivity for HIV or active hepatitis B or C.
  • Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking lenalidomide.
  • History of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months.
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Use of any other experimental drug or therapy within 28 days of baseline.
  • Concurrent use of other anti-cancer agents or treatments
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632359

Contacts
Contact: Alessandra Ferrajoli, M.D. 713-792-2063 aferrajo@mdanderson.org

Locations
United States, Texas
The University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Alessandra Ferrajoli, M.D.     713-792-2063     aferrajo@mdanderson.org    
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Alessandra Ferrajoli, M.D, M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: The University of Texas M. D. Anderson Cancer Center ( Alessandra Ferrajoli, M.D./Associate Professor )
Study ID Numbers: 2007-0213
Study First Received: March 3, 2008
Last Updated: February 17, 2009
ClinicalTrials.gov Identifier: NCT00632359     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Chronic Lymphocytic Leukemia
CLL
Lenalidomide
Revlimid

Study placed in the following topic categories:
Lymphatic Diseases
Leukemia
Chronic Lymphocytic Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, Lymphocytic, Chronic, B-Cell
Lenalidomide
Leukemia, B-cell, Chronic
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:
Leukemia, Lymphoid
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Lenalidomide
Pharmacologic Actions
Leukemia
Lymphatic Diseases
Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Leukemia, B-Cell
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on May 07, 2009