Lenalidomide and Rituximab in Treating Patients With Non-Hodgkin Lymphoma

NCT00848328 | Terminated Phase 2 DMC

• 4 other identifiers: 220942CDR0000634775CELGENE-RV-PI-NHL-0163UCD-197
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving lenalidomide together with rituximab works in treating patients with follicular or small lymphocytic non-Hodgkin lymphoma that has relapsed or not responded to treatment.

Conditions

Lymphoma

Keywords

recurrent small lymphocytic lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

• Response, as defined by complete response (CR), near CR, partial response, or stable disease at 4 months

  Responses will be assessed by the Revised Working Group Response Criteria for Malignant Lymphoma. A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease.

  4 months

Secondary Outcomes (4)

• Time to disease progression

  Up to two years

• Tolerability (type, frequency, severity, and relationship of adverse events to study treatment as assessed by NCI CTCAE v3.0)

  Up to two years

• Duration of response

  Up to two years

• Overall survival

  Up to two years

Study Arms (1)

Lenalidomide and Rituximab

EXPERIMENTAL

Rituximab 375 mg/m2/wk x 4 weeks, to begin Cycle 1, Day 15. Lenalidomide 20 mg daily, days 1-21 of a 28 day cycle, to begin Day 1 of cycle 1 and continue until disease progression.

Biological: Rituximab; Drug: Lenalidomide

Interventions

Rituximab BIOLOGICAL

Injection for Intravenous Use, 375 mg/m2/wk x 4 weeks, to begin Cycle 1, Day 15.

Also known as: Rituxan, MabThera

Lenalidomide and Rituximab

Lenalidomide DRUG

Supplied as 5mg capsules; Dosage: 20 mg daily, days 1-21 of a 28 day cycle, to begin Day 1 of cycle 1 and continue until disease progression.

Also known as: REVLIMID

Lenalidomide and Rituximab

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically\* confirmed non-Hodgkin lymphoma, including one of the following subtypes: * Grade 1, 2, or 3a (\> 15 centroblasts per high-power field with centrocytes present) follicular lymphoma according to WHO criteria * Small lymphocytic lymphoma * NOTE: \*Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies or extra-nodal biopsies; fine-needle aspirates are not acceptable for diagnosis. * At least one measurable lesion according to RECIST criteria * Measurable lymphadenopathy to follow with serial exam and/or imaging * Relapsed or refractory disease * Must have evidence of disease progression during or after last treatment * If previously treated with rituximab, must have disease progression within 6 months of last therapy OR if there was a prior response to rituximab, rituximab must not have been given within the past 6 months * No evidence of CNS metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 3 months * Absolute neutrophil count ≥ 1,000/mm³ * Platelet count ≥ 75,000/mm³ * Serum creatinine ≤ 2.0 mg/dL * Total bilirubin ≤ 2.0 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double method contraception for ≥ 28 days before, during, and for ≥ 28 days after completion of study therapy * HIV negative * Able to swallow lenalidomide * Able to take aspirin (81 or 325 mg) daily or low molecular weight heparin as prophylactic anticoagulation * No neuropathy ≥ grade 2 * No known active hepatitis A, B, or C * No other malignancies within the past 5 years except treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast * No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude the patient from signing the informed consent form * No condition, including the presence of laboratory abnormalities, that would preclude study participation or confound the ability to interpret study data * No known hypersensitivity to thalidomide or rituximab * No development of erythema nodosum, if characterized by a desquamating rash while taking thalidomide or similar drugs PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 4 weeks since prior anticancer therapy, including radiotherapy, hormonal therapy, or surgery * More than 28 days since prior experimental drug or therapy * No prior lenalidomide * No other concurrent anticancer agents or treatments, including radiotherapy or thalidomide * No other concurrent investigational agents * No concurrent sargramostim (GM-CSF) * No other concurrent antilymphoma therapy, including steroids (except for the treatment of hypersensitivity reactions)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, Davis: lead
• Celgene: collaborator

Study Sites (1)

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular

Interventions

Rituximab; Lenalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; 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

• Joseph M. Tuscano, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: August 25, 2008
• Primary Completion: June 28, 2023
• Study Completion: April 15, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

US (1)