Back to resultsRituximab and/or Lenalidomide in Treating Patients With Follicular Non-Hodgkin's Lymphoma That is Not Refractory to Rituximab
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rituximab
lenalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma
Eligibility Criteria
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
Sites / Locations
- Rebecca and John Moores UCSD Cancer Center
- Kaiser Permanente Medical Office -Vandever Medical Office
- Walter Reed Army Medical Center
- Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- CCOP - Mount Sinai Medical Center
- Illinois CancerCare - Bloomington
- Graham Hospital
- Illinois CancerCare - Canton
- Illinois CancerCare - Carthage
- Memorial Hospital
- University of Chicago Cancer Research Center
- Eureka Community Hospital
- Illinois CancerCare - Eureka
- Galesburg Clinic, PC
- Galesburg Cottage Hospital
- Illinois CancerCare - Galesburg
- Illinois CancerCare - Havana
- Mason District Hospital
- Illinois CancerCare - Kewanee Clinic
- Illinois CancerCare - Macomb
- McDonough District Hospital
- Illinois CancerCare - Monmouth
- BroMenn Regional Medical Center
- Community Cancer Center
- Illinois CancerCare - Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Illinois CancerCare - Pekin
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- Illinois CancerCare - Peru
- Illinois Valley Community Hospital
- Illinois CancerCare - Princeton
- Perry Memorial Hospital
- Illinois CancerCare - Spring Valley
- Fort Wayne Medical Oncology and Hematology
- Menorah Medical Center
- Saint Luke's Hospital - South
- Veterans Affairs Medical Center - Minneapolis
- Saint Luke's Cancer Institute at Saint Luke's Hospital
- St. Joseph Medical Center
- North Kansas City Hospital
- Heartland Hematology Oncology Associates, Incorporated
- CCOP - Kansas City
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Liberty Hospital
- Heartland Regional Medical Center
- Saint Joseph Oncology, Incorporated
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- Methodist Estabrook Cancer Center
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
- New Hampshire Oncology - Hematology, PA - Hooksett
- Lakes Region General Hospital
- Roswell Park Cancer Institute
- CCOP - Hematology-Oncology Associates of Central New York
- New York Weill Cornell Cancer Center at Cornell University
- Kinston Medical Specialists
- Wake Forest University Comprehensive Cancer Center
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
- Cancer Centers of the Carolinas - Easley
- Bon Secours St. Francis Health System
- Cancer Centers of the Carolinas - Faris Road
- Cancer Centers of the Carolinas - Grove Commons
- Greenville Hospital Cancer Center
- CCOP - Greenville
- Self Regional Cancer Center at Self Regional Medical Center
- Cancer Centers of the Carolinas - Greer Medical Oncology
- Cancer Centers of the Carolinas - Seneca
- Cancer Centers of the Carolinas - Spartanburg
- Mountainview Medical
- Fletcher Allen Health Care - University Health Center Campus
- Danville Regional Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Arm I - rituximab
Arm II - lenalidomide
Arm III - lenalidomide and rituximab
Arm Description
Patients receive rituximab IV on days 1, 8, 15, and 22.
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.
Patients receive lenalidomide as in arm II. Patients also receive rituximab IV on days 8, 15, 22 and 29.
Outcomes
Primary Outcome Measures
Overall Response Rate
Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a >/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.
Time to Progression
Time to progression (TTP) is defined as the time from study entry until progression or death without progression. The median TTP with 95% CI was estimated using the Kaplan-Meier method.
Secondary Outcome Measures
Full Information
NCT ID
NCT00238238
First Posted
October 12, 2005
Last Updated
February 6, 2017
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00238238
Brief Title
Rituximab and/or Lenalidomide in Treating Patients With Follicular Non-Hodgkin's Lymphoma That is Not Refractory to Rituximab
Official Title
A Randomized Phase II Trial of Rituximab Versus Lenalidomide (REVLIMID™, Cc-5013) (IND#73034) Versus Rituximab + Lenalidomide in Recurrent Follicular Non-Hodgkin Lymphoma (NHL) That is Not Rituximab-Refractory
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I - rituximab
Arm Type
Active Comparator
Arm Description
Patients receive rituximab IV on days 1, 8, 15, and 22.
Arm Title
Arm II - lenalidomide
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm III - lenalidomide and rituximab
Arm Type
Experimental
Arm Description
Patients receive lenalidomide as in arm II. Patients also receive rituximab IV on days 8, 15, 22 and 29.
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
Response is assessed by investigator according to International Working Group (IWG) criteria. A complete response requires disappearance of all evidence of disease. A partial response is a >/= 50% decrease in the sum of products of 6 largest dominant nodes or nodal masses as well as for splenic and hepatic nodules. No increase in size of nodes, liver or spleen and no new sites of disease.
Time Frame
Duration of treatment (12 cycles)
Title
Time to Progression
Description
Time to progression (TTP) is defined as the time from study entry until progression or death without progression. The median TTP with 95% CI was estimated using the Kaplan-Meier method.
Time Frame
Up to 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P. Leonard, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Study Chair
Facility Information:
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
Kaiser Permanente Medical Office -Vandever Medical Office
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5001
Country
United States
Facility Name
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Illinois CancerCare - Bloomington
City
Bloomington%
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Graham Hospital
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Illinois CancerCare - Canton
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Illinois CancerCare - Carthage
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Memorial Hospital
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Eureka Community Hospital
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Illinois CancerCare - Eureka
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Galesburg Clinic, PC
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Galesburg Cottage Hospital
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare - Galesburg
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare - Havana
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Mason District Hospital
City
Havana
State/Province
Illinois
ZIP/Postal Code
62644
Country
United States
Facility Name
Illinois CancerCare - Kewanee Clinic
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
Illinois CancerCare - Macomb
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
McDonough District Hospital
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Illinois CancerCare - Monmouth
City
Monmouth
State/Province
Illinois
ZIP/Postal Code
61462
Country
United States
Facility Name
BroMenn Regional Medical Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Illinois CancerCare - Community Cancer Center
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Community Hospital of Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Ottawa
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Cancer Treatment Center at Pekin Hospital
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Illinois CancerCare - Pekin
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Proctor Hospital
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Oncology Hematology Associates of Central Illinois, PC - Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
Illinois CancerCare - Peru
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois Valley Community Hospital
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois CancerCare - Princeton
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Perry Memorial Hospital
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Illinois CancerCare - Spring Valley
City
Spring Valley
State/Province
Illinois
ZIP/Postal Code
61362
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Saint Luke's Hospital - South
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Name
Veterans Affairs Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Saint Luke's Cancer Institute at Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
St. Joseph Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
North Kansas City Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
Heartland Hematology Oncology Associates, Incorporated
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64118
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Saint Luke's East - Lee's Summit
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64086
Country
United States
Facility Name
Liberty Hospital
City
Liberty
State/Province
Missouri
ZIP/Postal Code
64068
Country
United States
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Saint Joseph Oncology, Incorporated
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Methodist Estabrook Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
CCOP - Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
New Hampshire Oncology - Hematology, PA - Hooksett
City
Hooksett
State/Province
New Hampshire
ZIP/Postal Code
03106
Country
United States
Facility Name
Lakes Region General Hospital
City
Laconia
State/Province
New Hampshire
ZIP/Postal Code
03246
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
CCOP - Hematology-Oncology Associates of Central New York
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
New York Weill Cornell Cancer Center at Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Kinston Medical Specialists
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Cancer Centers of the Carolinas - Easley
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Bon Secours St. Francis Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Cancer Centers of the Carolinas - Faris Road
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Cancer Centers of the Carolinas - Grove Commons
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Greenville Hospital Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Self Regional Cancer Center at Self Regional Medical Center
City
Greenwood
State/Province
South Carolina
ZIP/Postal Code
29646
Country
United States
Facility Name
Cancer Centers of the Carolinas - Greer Medical Oncology
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Cancer Centers of the Carolinas - Seneca
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
Cancer Centers of the Carolinas - Spartanburg
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Facility Name
Mountainview Medical
City
Berlin
State/Province
Vermont
ZIP/Postal Code
05602
Country
United States
Facility Name
Fletcher Allen Health Care - University Health Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26304886
Citation
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 Oncol. 2015 Nov 1;33(31):3635-40. doi: 10.1200/JCO.2014.59.9258. Epub 2015 Aug 24.
Results Reference
result
Learn more about this trial
Rituximab and/or Lenalidomide in Treating Patients With Follicular Non-Hodgkin's Lymphoma That is Not Refractory to Rituximab
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