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

NCT00439231 | Completed Phase 2 Results DMC

• 2 other identifiers: 07010407-H-0104
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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. ...

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  24 weeks of lenalidomide therapy

Study Arms (1)

Lenalidomide (Revlimid) subjects

EXPERIMENTAL

Lenalidomide regimen testing to determine efficacy for CLL/ SLL subjects

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Lenalidomide (Revlimid) regimen testing to determine efficacy for SLL/ CLL subjects

Also known as: Revlimid

Lenalidomide (Revlimid) subjects

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Georg Aue, M.D.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• 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.

  PMID: 21812019 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Georg Aue
• Organization: NHLBI/NIH

AueG@nhlbi.nih.gov

301.451.7141

Study Officials

• Georg Aue, MD

  NIH National Heart, Lung, and Blood Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: NHLBI Hematolgy Clinician

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 23, 2007
• Study Start: February 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 13, 2014
• Results First Posted: January 13, 2014

Record last verified: 2013-11

Locations

US (1)