Lenalidomide in Treating Patients With High-Risk Chronic Lymphocytic Leukemia

NCT01271283 | Withdrawn Phase 2

• 5 other identifiers: NCI-2011-02568CDR0000692070RPCI # I 1749108254P30CA016056
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II clinical trial is studying how well lenalidomide works in treating patients with high-risk chronic lymphocytic leukemia. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.

Conditions

Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage IV Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• Time to progression

  From the start of lenalidomide therapy to time of disease progression, assessed up to 24 months

Secondary Outcomes (1)

• Maximal clinical response (complete and partial response)

  Up to 24 months

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (by morphological criteria but have persistent minimal residual disease by molecular criteria) or partial response may continue treatment beyond 8 courses. Patients may undergo bone marrow, peripheral blood, and/or lymph node sample collection at baseline and periodically during study for correlative studies.

Other: Diagnostic Laboratory Biomarker Analysis; Drug: Lenalidomide

Interventions

Diagnostic Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I

Lenalidomide DRUG

Given orally

Also known as: CC-5013, CC5013, CDC 501, Revlimid

Arm I

Eligibility Criteria

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

You may qualify if:

• Definitive diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
• Must have high-risk B-CLL as defined by ≥ one of the following:
• High-risk cytogenetics (either 17p deletion and/or 11q deletion)
• Unmutated immunoglobulin heavy chain gene rearrangement
• Zap-70 and CD38 expression on leukemic cells will not be used as eligibility criteria for enrollment into the clinical trial
• No prior treatment for the management of B-CLL
• Patients must have B-CLL requiring therapy as defined by the IWCLL criteria
• Must have measurable disease meeting one of the following criteria:
• Absolute lymphocyte count \> 5,000/μL
• Measurable lymphadenopathy or organomegaly
• No tumor lysis syndrome (TLS) by Cairo-Bishop definition
• Patients with correction of electrolyte abnormalities allowed
• ECOG performance status 0-2
• ANC ≥ 1,500/mm³
• Platelet count ≥ 75,000/mm³

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

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

Study Officials

• Asher Chanan-Khan

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 6, 2011
• Study Start: December 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 4, 2015

Record last verified: 2011-11

Locations

US (1)