Lenalidomide in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Georg Aue, M.D., National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00439231
First received: February 22, 2007
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

This study will evaluate the safety and effectiveness of a new drug called lenalidomide (Revlimid) for treating patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who relapsed after their initial treatment.

Patients 21 years of age and older with CLL or SLL who have previously received standard treatment may be eligible for this study.

Participants take lenalidomide capsules once a day for 21 days, followed by 21 days off the drug. This constitutes one treatment cycle. Treatment continues for four cycles as long as the medicine is tolerated. After four cycles, patients who respond completely continue treatment for another two cycles; patients who respond partially continue treatment for another four cycles; and patients who do not respond stop treatment but continue to be followed for safety.

...


Condition Intervention Phase
Chronic Lymphocytic Leukemia (CLL)
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 Revlimid(Registered Trademark) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen [ Time Frame: 24 weeks of lenalidomide therapy ] [ Designated as safety issue: No ]
    To establish the overall response rate based on peripheral blood measures (absolute neutrophil count, platelets, and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after first dose of lenalidomide using this dosing regimen


Enrollment: 33
Study Start Date: February 2007
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide (Revlimid) subjects
Lenalidomide regimen testing to determine efficacy for CLL/ SLL subjects
Drug: Lenalidomide
Lenalidomide (Revlimid) regimen testing to determine efficacy for SLL/ CLL subjects
Other Name: Revlimid

Detailed Description:

There is evidence that lenalidomide has single agent activity in chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL). Optimal dosing of lenalidomide in CLL has not been established yet. A pilot clinical trial in CLL studied single agent lenalidomide cycled every 4 weeks with 25 mg for three weeks on and one week off drug. In this trial dose reductions have been necessary secondary to prolonged neutropenia or thrombocytopenia in a majority of patients. However, there was also remarkable efficacy and evidence for an immune stimulatory effect of lenalidomide. Therefore, we propose this phase II trial using 20 mg lenalidomide (Revlimid(Registered Trademark)) 3 weeks on and 3 weeks off for 4 cycles in subjects who have been previously treated for chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL). Subjects with at least partial response (PR) may go on to receive 4 additional cycles.

The primary objective of the trial is to test the efficacy of a more tolerable dosing scheme of lenalidomide.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).
    2. Failed prior standard of care therapy for CLL.
    3. Neutrophil count (ANC) greater than or equal to 500/microliter (mcL).
    4. Platelet count greater than or equal to 20,000/mcL.
    5. Age 21-99.

EXCLUSION CRITERIA:

  1. Chronic or current clinically significant infection, including HIV positivity or uncontrolled infection.
  2. Eastern Cooperative Oncology Group (ECOG) performance greater than 2.
  3. Other concurrent anticancer therapies.
  4. Less than 4 weeks from last systemic therapy for CLL. Steroids up to 2 weeks before the start of treatment are permissible.
  5. Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy.
  6. Creatinine greater than 1.5 times the upper limit of normal.
  7. Women who are pregnant or nursing, as well as women of childbearing potential who are unwilling to use a dual method of contraception.
  8. Men who are unwilling to use a barrier protection.
  9. Inability to understand the investigational nature of the study; inability to provide informed consent.
  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: NCT00439231

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Georg Aue, M.D.
Investigators
Principal Investigator: Georg Aue, MD NIH National Heart, Lung and Blood Institute
  More Information

Additional Information:
No publications provided by National Institutes of Health Clinical Center (CC)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Georg Aue, M.D., NHLBI Hematolgy Clinician, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00439231     History of Changes
Obsolete Identifiers: NCT00465127
Other Study ID Numbers: 070104, 07-H-0104
Study First Received: February 22, 2007
Results First Received: September 19, 2011
Last Updated: November 14, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Monoclonal Antibody Therapy
Biologic Response Modifier Therapy
CLL
SLL
chemo-care (CC) 5013- Revlimid
Chronic Lymphocytic Leukemia
Small Lymphocytic Leukemia

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
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 28, 2014