Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) Age 65 and Older

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00535873
First received: September 25, 2007
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

Primary Objective:

  • To assess the activity of lenalidomide in patients with previously untreated chronic lymphocytic leukemia (CLL) age 65 and older.

Secondary Objective:

  • To assess the tolerability of lenalidomide in patients with untreated CLL age 65 and older

Condition Intervention Phase
Leukemia
CLL
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Drug: Lenalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia Age 65 or Older.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: From 3 cycles (90 days) up to 6 cycles (approximately 180 days) ] [ Designated as safety issue: No ]
    ORR defined as number of participants with best response of Complete or Partial response out of total number of participants. Response assessed using the NCI Working Group criteria for response following 3 cycles, 6 cycles and yearly thereafter.


Enrollment: 61
Study Start Date: October 2007
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide
Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
Drug: Lenalidomide
Starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
Other Names:
  • Revlimid
  • CC-5013

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. 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.
  2. Age 65 or older
  3. Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0-2.
  4. 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 alanine aminotransferase (ALT) less or equal 2 upper limit of normal (ULN).
  5. Able to understand and sign Informed Consent after the investigational nature, study design, risks and benefits have been explained.
  6. Able to adhere to the study visit schedule and other protocol requirements.
  7. 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.
  8. 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
  9. 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.
  10. 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.
  11. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
  12. All patients must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to Acetylsalicylic Acid (ASA) may use warfarin or low molecular weight heparin.

Exclusion Criteria:

  1. Known sensitivity to thalidomide or its derivatives.
  2. Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
  3. Known positivity for HIV or active hepatitis (B or C).
  4. 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.
  5. Active cardiovascular disease as defined by the New York Heart Association Class 3 or 4.
  6. History of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  7. Concurrent use of other chemotherapy agents.
  8. Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking lenalidomide.
  9. No known history of tuberculosis or recent exposure to tuberculosis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535873

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
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 by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00535873     History of Changes
Other Study ID Numbers: 2006-0715
Study First Received: September 25, 2007
Results First Received: June 19, 2013
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
CLL
chronic lymphocytic leukemia
SLL
small lymphocytic lymphoma
Untreated CLL
Lenalidomide
CC-5013
Revlimid
Oral

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014