Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non-Hodgkin's Lymphoma

NCT01316523 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: 215856UCDCC#224RV_PI_NHL_0488
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Lenalidomide has been shown to have single agent activity in indolent Non-Hodgkin's Lymphoma. It is approved for the treatment of multiple myeloma and myelodysplastic syndrome. Rituximab is effective as a single agent and in combination with chemotherapy for indolent Non-Hodgkin's Lymphoma. The purpose of this study is to see how well giving lenalidomide together with rituximab works in treating patients with previously untreated indolent Non Hodgkin's Lymphoma. Lenalidomide will taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, unacceptable side effects or after twelve cycles if the patient is responding well. Rituximab 375 mg/m2/wk x 4 weeks will begin on Day 15 of cycle 1. After 4 cycles of therapy, if patients respond well to treatment, patients will receive a second course of Rituximab. Blood samples will be collected to assess how the immune system is functioning.

Conditions

Non Hodgkin's Lymphoma

Keywords

Lenalidomide; Rituximab; untreated indolent Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• Response Rate to Treatment

  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. Response Rate defined as the proportion of patients whose best response was complete response (CR; confirmed or unconfirmed) or partial response (PR).

  4 months

Secondary Outcomes (4)

• Time to Next Treatment.

  Up to about 13 years.

• Overall Survival

  Up to about 13 years

• Number of Patients Experiencing Treatment-related Adverse Events.

  Up to about 12 years.

• Duration of Response From Start of Therapy

  Up to 14 months.

Study Arms (1)

Lenalidomide + Rituximab

EXPERIMENTAL

Patients will receive lenalidomide 20 mg daily (oral), on days 1-21 of a 28 day cycle. Rituximab 375 mg/m2 (into the vein) will be administered weekly for 4 doses starting day 15 of cycle 1, to be repeated if patient does not achieve a complete response after cycle 4, on days 1, 8, 15 and 22 of cycle 5.

Drug: Rituximab; Drug: Lenalidomide

Interventions

Rituximab DRUG

Rituximab 375 mg/m2/wk x 4 weeks, to begin Day 15 of cycle 1. After 4 cycles of therapy if patient does not respond to treatment, the patient will receive a second course of Rituximab.

Also known as: Rituxan

Lenalidomide + Rituximab

Lenalidomide DRUG

Lenalidomide will be taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, there are too many side effects, or after twelve cycles if the patient responds to treatment.

Also known as: Revlimid

Lenalidomide + Rituximab

Eligibility Criteria

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

You may qualify if:

• All patients must be informed of the investigative nature of the clinical trial and given written informed consent in accordance with institutional and federal guidelines.
• Age greater than or equal to 18 years at the time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements.
• Previously untreated, histologically confirmed indolent lymphoma including follicle cell lymphoma, WHO classification, grade I or II, and marginal zone lymphoma. Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies. Fine needle aspirates are not acceptable.
• At least one measurable lesion according to the International Working Group Response criteria for lymphomas. There must be measurable lymphadenopathy to follow with serial exam and/or imaging.
• Submission of original biopsy for review by local staff hematopathologist.
• ECOG performance status of 0 -2 at study entry.
• No major organ dysfunction with laboratory test results within these ranges:
• Absolute neutrophil count greater than or equal to 1000 /uL
• Platelet count greater than or equal to 75 x 109/L
• Total bilirubin less than or equal to 2.0 mg/dL.
• HIV negative
• Subjects must have calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula. See section below, "Dosing Regimen", regarding lenalidomide dose adjustment for calculated creatinine clearance ≥ 30ml/min and \< 60ml/min.
• Life expectancy of greater than 3 months.
• Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.

You may not qualify if:

• Any prior treatment for Non-Hodgkin's Lymphoma.
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or breast-feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Use of any other experimental drug or therapy within 28 days of baseline.
• Known hypersensitivity to thalidomide or rituximab.
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Any prior use of lenalidomide.
• Concurrent use of other anti-cancer agents or treatments.
• Known positive for HIV
• Known active hepatitis, type A, B or C.
• Evidence for CNS metastatic disease
• Subjects with ≥ Grade 2 neuropathy

Sponsors & Collaborators

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

Study Sites (2)

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Sutter Pacific Medical Foundation

Santa Rosa, California, 95403, United States

Location

Related Publications (1)

• Tuscano JM, Dutia M, Chee K, Brunson A, Reed-Pease C, Abedi M, Welborn J, O'Donnell RT. Lenalidomide plus rituximab can produce durable clinical responses in patients with relapsed or refractory, indolent non-Hodgkin lymphoma. Br J Haematol. 2014 May;165(3):375-81. doi: 10.1111/bjh.12755. Epub 2014 Mar 7.

  PMID: 24606326 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

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

Results Point of Contact

• Title: Leslie Garcia
• Organization: University of California, Davis

lesgarcia@ucdavis.edu

916-734-0156

Study Officials

• Joseph Tuscano, MD

  University of California, Davis

  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: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Internal Medicine

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: March 16, 2011
• Study Start: December 1, 2010
• Primary Completion: September 12, 2023
• Study Completion: April 14, 2024
• Last Updated: November 21, 2025
• Results First Posted: November 21, 2025

Record last verified: 2025-11

Locations

US (2)