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

Primary Purpose

Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lenalidomide
Sponsored by
Georg Aue, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia (CLL) focused on measuring Monoclonal Antibody Therapy, Biologic Response Modifier Therapy, CLL, SLL, chemo-care (CC) 5013- Revlimid, Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  • 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.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lenalidomide (Revlimid) subjects

Arm Description

Lenalidomide regimen testing to determine efficacy for CLL/ SLL subjects

Outcomes

Primary Outcome Measures

To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen
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

Secondary Outcome Measures

Full Information

First Posted
February 22, 2007
Last Updated
November 14, 2013
Sponsor
Georg Aue, M.D.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00439231
Brief Title
Lenalidomide in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Official Title
A Phase II Study of Lenalidomide Revlimid(Registered Trademark) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Georg Aue, M.D.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. ...
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma
Keywords
Monoclonal Antibody Therapy, Biologic Response Modifier Therapy, CLL, SLL, chemo-care (CC) 5013- Revlimid, Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenalidomide (Revlimid) subjects
Arm Type
Experimental
Arm Description
Lenalidomide regimen testing to determine efficacy for CLL/ SLL subjects
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
Lenalidomide (Revlimid) regimen testing to determine efficacy for SLL/ CLL subjects
Primary Outcome Measure Information:
Title
To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen
Description
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
Time Frame
24 weeks of lenalidomide therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). Failed prior standard of care therapy for CLL. Neutrophil count (ANC) greater than or equal to 500/microliter (mcL). Platelet count greater than or equal to 20,000/mcL. Age 21-99. EXCLUSION CRITERIA: Chronic or current clinically significant infection, including HIV positivity or uncontrolled infection. Eastern Cooperative Oncology Group (ECOG) performance greater than 2. Other concurrent anticancer therapies. Less than 4 weeks from last systemic therapy for CLL. Steroids up to 2 weeks before the start of treatment are permissible. 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. Creatinine greater than 1.5 times the upper limit of normal. Women who are pregnant or nursing, as well as women of childbearing potential who are unwilling to use a dual method of contraception. Men who are unwilling to use a barrier protection. Inability to understand the investigational nature of the study; inability to provide informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Aue, MD
Organizational Affiliation
NIH National Heart, Lung and Blood Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21812019
Citation
Aue G, Nelson Lozier J, Tian X, Cullinane AM, Soto S, Samsel L, McCoy P, Wiestner A. Inflammation, TNFalpha and endothelial dysfunction link lenalidomide to venous thrombosis in chronic lymphocytic leukemia. Am J Hematol. 2011 Oct;86(10):835-40. doi: 10.1002/ajh.22114. Epub 2011 Aug 2.
Results Reference
derived
Links:
URL
http://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2007-H-0104.html
Description
NIH Clinical Center Detailed Web Page

Learn more about this trial

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

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