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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00238238
Other study ID # CALGB-50401
Secondary ID CALGB-50401U10CA
Status Active, not recruiting
Phase Phase 2
First received October 12, 2005
Last updated August 11, 2016
Start date March 2006

Study information

Verified date August 2016
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 180
Est. completion date
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility - Documentation of Disease

- Previously treated, histologically confirmed follicle center cell lymphoma, World Health Organization (WHO) classification, grade 1, 2, or 3a

- Institutional flow cytometry or immunohistochemistry must confirm Cluster of Differentiation 20 (CD20) antigen expression.

- Prior Treatment

- Patient must have been treated with rituximab either alone or in combination with chemotherapy.

- Patient must have a time to progression of = 6 months from last rituximab dose.

- No corticosteroids within two weeks prior to study, except for maintenance therapy for a non-malignant disease. Maintenance therapy dose may not exceed 20 mg/day prednisone or equivalent.

- No prior radioimmunotherapy within 12 months of study entry.

- Age = 18 years.

- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

- Measurable disease must be present either on physical examination or imaging studies. Non-measurable disease alone is not acceptable. Any tumor mass >1 cm is acceptable.Lesions that are considered non-measurable include the following:

- Bone lesions

- Ascites

- Pleural/pericardial effusion

- Lymphangitis cutis/pulmonis

- Bone marrow

- No known Central Nervous System (CNS) involvement by lymphoma.

- No known Human Immunodeficiency Virus (HIV) infection.

- Non-pregnant and non-nursing.

- Patients with a "currently active" second malignancy, other than non-melanoma skin cancers, are not eligible.

- 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
rituximab
Given IV
Drug:
lenalidomide
Given orally

Locations

Country Name City State
United States Mountainview Medical Berlin Vermont
United States Illinois CancerCare - Bloomington Bloomington% Illinois
United States Roswell Park Cancer Institute Buffalo New York
United States Fletcher Allen Health Care - University Health Center Campus Burlington Vermont
United States Graham Hospital Canton Illinois
United States Illinois CancerCare - Canton Canton Illinois
United States Illinois CancerCare - Carthage Carthage Illinois
United States Memorial Hospital Carthage Illinois
United States University of Chicago Cancer Research Center Chicago Illinois
United States Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus Ohio
United States New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord New Hampshire
United States Danville Regional Medical Center Danville Virginia
United States Cancer Centers of the Carolinas - Easley Easley South Carolina
United States CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York
United States Eureka Community Hospital Eureka Illinois
United States Illinois CancerCare - Eureka Eureka Illinois
United States Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale Florida
United States Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana
United States Galesburg Clinic, PC Galesburg Illinois
United States Galesburg Cottage Hospital Galesburg Illinois
United States Illinois CancerCare - Galesburg Galesburg Illinois
United States Bon Secours St. Francis Health System Greenville South Carolina
United States Cancer Centers of the Carolinas - Faris Road Greenville South Carolina
United States Cancer Centers of the Carolinas - Grove Commons Greenville South Carolina
United States CCOP - Greenville Greenville South Carolina
United States Greenville Hospital Cancer Center Greenville South Carolina
United States Self Regional Cancer Center at Self Regional Medical Center Greenwood South Carolina
United States Cancer Centers of the Carolinas - Greer Medical Oncology Greer South Carolina
United States Illinois CancerCare - Havana Havana Illinois
United States Mason District Hospital Havana Illinois
United States New Hampshire Oncology - Hematology, PA - Hooksett Hooksett New Hampshire
United States Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter Florida
United States CCOP - Kansas City Kansas City Missouri
United States Heartland Hematology Oncology Associates, Incorporated Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City Missouri
United States St. Joseph Medical Center Kansas City Missouri
United States Illinois CancerCare - Kewanee Clinic Kewanee Illinois
United States Kinston Medical Specialists Kinston North Carolina
United States Rebecca and John Moores UCSD Cancer Center La Jolla California
United States Lakes Region General Hospital Laconia New Hampshire
United States CCOP - Nevada Cancer Research Foundation Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Liberty Hospital Liberty Missouri
United States Illinois CancerCare - Macomb Macomb Illinois
United States McDonough District Hospital Macomb Illinois
United States CCOP - Mount Sinai Medical Center Miami Beach Florida
United States Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota
United States Illinois CancerCare - Monmouth Monmouth Illinois
United States New York Weill Cornell Cancer Center at Cornell University New York New York
United States BroMenn Regional Medical Center Normal Illinois
United States Community Cancer Center Normal Illinois
United States Illinois CancerCare - Community Cancer Center Normal Illinois
United States Methodist Estabrook Cancer Center Omaha Nebraska
United States Community Hospital of Ottawa Ottawa Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's Hospital - South Overland Park Kansas
United States Cancer Treatment Center at Pekin Hospital Pekin Illinois
United States Illinois CancerCare - Pekin Pekin Illinois
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois CancerCare - Peru Peru Illinois
United States Illinois Valley Community Hospital Peru Illinois
United States Illinois CancerCare - Princeton Princeton Illinois
United States Perry Memorial Hospital Princeton Illinois
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Saint Joseph Oncology, Incorporated Saint Joseph Missouri
United States Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri
United States Kaiser Permanente Medical Office -Vandever Medical Office San Diego California
United States Cancer Centers of the Carolinas - Seneca Seneca South Carolina
United States Cancer Centers of the Carolinas - Spartanburg Spartanburg South Carolina
United States Illinois CancerCare - Spring Valley Spring Valley Illinois
United States Walter Reed Army Medical Center Washington District of Columbia
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Leonard JP, Jung SH, Johnson J, Pitcher BN, Bartlett NL, Blum KA, Czuczman M, Giguere JK, Cheson BD. Randomized Trial of Lenalidomide Alone Versus Lenalidomide Plus Rituximab in Patients With Recurrent Follicular Lymphoma: CALGB 50401 (Alliance). J Clin O — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Response rate (overall and complete) at 2, 4, 6, 9, 12, 15, 18, and 24 months, and then yearly for up to 10 years Up to 10 years No
Primary Time to progression for up to 10 years Up to 10 years No
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