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Rituximab and/or Lenalidomide...

Rituximab and/or Lenalidomide in Treating Patients With Follicular Non-Hodgkin's Lymphoma That is Not Refractory to Rituximab

Last Updated: 2017-03-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2015-08-31

Brief Summary

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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. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide may also stop the growth of non-Hodgkin's lymphoma by blocking blood flow to the cancer. Giving rituximab together with lenalidomide may kill more cancer cells. This randomized phase II trial is studying how well rituximab and/or lenalidomide work in treating patients with follicular non-Hodgkin's lymphoma that is not refractory to rituximab.

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Detailed Description

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Outline:

This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms. Please see the "Arms" section for a description of each treatment arm. The primary and secondary objectives of the study are provided below.

Primary Objectives:

* To determine the response rate (overall and complete) after lenalidomide therapy and rituximab + lenalidomide in follicular NHL patients who have relapsed.
* To determine time to progression after lenalidomide therapy and rituximab and lenalidomide in follicular NHL patients who have relapsed.

Secondary Objectives:

* To compare the time to progression of the previous rituximab regimen to that obtained subsequently to lenalidomide therapy and rituximab + lenalidomide.
* To determine the toxicity profile of lenalidomide therapy and of rituximab and lenalidomide in follicular NHL patients who have received a previous rituximab regimen.
* To correlate Fc receptor polymorphism profiling with response to lenalidomide or rituximab + lenalidomide in previously treated patients with follicular NHL who have relapsed.
* To evaluate changes in Natural Killer (NK) cells, activated NK cells, activated T-cells and several plasma cytokines followed by rituximab therapy and correlation of observed changes to objective response rates.

After completion of study treatment, patients are followed for up to 10 years from study entry.

Conditions

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Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I - rituximab

Patients receive rituximab IV on days 1, 8, 15, and 22.

Group Type ACTIVE_COMPARATOR

rituximab

Intervention Type BIOLOGICAL

Given IV

Arm II - lenalidomide

Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

lenalidomide

Intervention Type DRUG

Given orally

Arm III - lenalidomide and rituximab

Patients receive lenalidomide as in arm II. Patients also receive rituximab IV on days 8, 15, 22 and 29.

Group Type EXPERIMENTAL

rituximab

Intervention Type BIOLOGICAL

Given IV

lenalidomide

Intervention Type DRUG

Given orally

Interventions

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rituximab

Given IV

Intervention Type BIOLOGICAL

lenalidomide

Given orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with a recent history (within 3 months of study entry) of Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) are not eligible.
* Required Initial Laboratory Values:

* Absolute Neutrophil Count (ANC) ≥ 1000/µL
* Platelet count ≥ 75,000/µL
* Creatinine \< 1.5 x Upper Limit of Normal (ULN) unless attributed to lymphoma or calculated clearance \> 50 mL/min (patients on dialysis are not eligible)
* Total Bilirubin ≤ 2 x ULN unless attributed to lymphoma or Gilbert's disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John P. Leonard, MD

Role: STUDY_CHAIR

Weill Medical College of Cornell University

Locations

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Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Site Status

Kaiser Permanente Medical Office -Vandever Medical Office

San Diego, California, United States

Site Status

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

Jupiter, Florida, United States

Site Status

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

Illinois CancerCare - Bloomington

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Illinois CancerCare - Canton

Canton, Illinois, United States

Site Status

Illinois CancerCare - Carthage

Carthage, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Illinois CancerCare - Eureka

Eureka, Illinois, United States

Site Status

Galesburg Clinic, PC

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Illinois CancerCare - Galesburg

Galesburg, Illinois, United States

Site Status

Illinois CancerCare - Havana

Havana, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Illinois CancerCare - Kewanee Clinic

Kewanee, Illinois, United States

Site Status

Illinois CancerCare - Macomb

Macomb, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

Illinois CancerCare - Monmouth

Monmouth, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Illinois CancerCare - Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Illinois CancerCare - Pekin

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Illinois CancerCare - Peru

Peru, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

Illinois CancerCare - Princeton

Princeton, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Illinois CancerCare - Spring Valley

Spring Valley, Illinois, United States

Site Status

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Site Status

Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Saint Luke's Hospital - South

Overland Park, Kansas, United States

Site Status