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Lenalidomide as Initial Treatment of Patients With CLL Age 65 and Older
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, August 2008
First Received: September 25, 2007   Last Updated: November 13, 2008   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
Celgene Corporation
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00535873
  Purpose

The goal of this clinical research study is to find out if Revlimid™ (lenalidomide) can help to control CLL in patients 65 years of age or older.The safety of this drug will also be studied.

Optional Procedures: You will be asked to have additional blood drawn to look at biomarkers (levels of substances produced by the body when cancer is present) that can be affected by treatment with lenalidomide. The ability of lenalidomide to block the growth of the leukemia cells and to affect the cells in your immune system will also be checked.

You will also be asked to answer questionnaires about symptoms you may be experiencing.


Condition Intervention Phase
Leukemia
CLL
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Drug: Lenalidomide
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma
Drug Information available for: Lenalidomide CC 5013
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia Age 65 or Older - RV-CLL-PI-0188

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

Primary Outcome Measures:
  • To assess the activity of lenalidomide in patients with previously untreated CLL age 65 and older. [ Time Frame: October 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the activity of lenalidomide in patients with previously untreated CLL age 65 and older. [ Time Frame: October 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2007
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Lenalidomide
lenalidomide orally, daily at 5mg daily for 56 days followed by individual titration up of 5mg increments every 28 days to reach a maximum dose of 25mg daily based on patient tolerance.

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Patients with untreated CLL or small lymphocytic lymphoma (SLL) with indication to treatment according to NCI Working Group guidelines.Patients that have received single agent rituximab will be allowed to participate in this study.
  • Age 65 or older
  • ECOG/WHO performance status of 0-2.
  • Adequate renal function indicated by serum creatinine less or equal to 2 and adequate hepatic function indicated as total bilirubin less or equal to upper level of normal and as ALT less or equal 2 ULN.
  • Able to understand and sign Informed Consent after the investigational nature, study design, risks and benefits have been explained.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation can be enrolled in the study as long as they have a reasonable expectation to have been cured with treatment modality received.
  • 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; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). 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
  • Continued from above. from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.
  • Men must agree to use a condom during sexual contact with a female of child bearing potential 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. See Appendix J: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND also Appendix M: Education and Counseling Guidance Document.
  • All patients must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin.

Exclusion Criteria:

  • Known sensitivity to thalidomide or its derivatives.
  • Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
  • Known positivity for HIV or active hepatitis (B or C).
  • A serious medical condition, laboratory abnormality or psychiatric illness that would interfere with the ability of the patient to participate in this program according to the judgement of the Principal Investigator.
  • Active cardiovascular disease as defined by the New York Heart Association Class 3 or 4.
  • History of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  • Concurrent use of other chemotherapy agents.
  • Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking lenalidomide.
  • No known history of tuberculosis or recent exposure to tuberculosis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535873

Contacts
Contact: Alessandra Ferrajoli, M.D. 713-792-2063

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        
Principal Investigator: Alessandra Ferrajoli, M.D.            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
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./ Assistant Professor )
Study ID Numbers: 2006-0715
Study First Received: September 25, 2007
Last Updated: November 13, 2008
ClinicalTrials.gov Identifier: NCT00535873     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Lenalidomide
Leukemia
CLL
chronic lymphocytic leukemia
SLL
small lymphocytic lymphoma

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
Lymphoma

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
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009