Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.
Conditions
Lymphoma, Non-Hodgkin
Conditions: official terms
Lymphoma - Lymphoma, Mantle-Cell - Lymphoma, Non-Hodgkin
Conditions: Keywords
Lymphoma, Mantle cell Lymphoma, Follicular Lymphoma, Marginal zone Lymphoma, Lenalidomide treatment, rituximab treatment, Non Hodgkins Lymphoma
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Lenalidomide Type: Drug
Name: Rituximab Type: Drug
Overall Status
Recruiting
Summary
This Phase 3B multicenter, randomized (stratified by histology, lines of anti-lymphoma therapy and age), open label study will enroll subjects with relapsed/refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) or mantle cell lymphoma (MZL). All subjects will receive 12 Cycles of lenalidomide plus rituximab induction therapy. The study is designed to compare the efficacy and safety of two maintenance regimens following induction therapy. Subjects will be randomized at study start to lenalidomide plus rituximab combination therapy (for 18 Cycles) followed by lenalidomide single-agent maintenance (to progression; Arm A, experimental) versus rituximab single-agent maintenance (for 18 Cycles; Arm B, control). The study is divided into a Screening Period, a Treatment Period (induction and maintenance), and a Follow up Period. Approximately 500 subjects are planned to be randomized.
Detailed Description
Follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) are cancers of the B lymphocyte, a type of white blood cell. Lenalidomide is an immunomodulatory drug (a drug that affects the immune system) which alters the body's immune system and it may also interfere with the development of tiny blood vessels involved in tumor growth. Therefore, lenalidomide may reduce or prevent the growth of cancer cells. Lenalidomide has also been shown to restore the immune cells' ability to attack and kill tumor cells, an ability that may be inhibited by FL and other lymphomas. The combination of rituximab and lenalidomide may eliminate the cancer while restoring the immune system's ability to attack tumor cells.

Subjects must have an investigator assessed diagnosis of relapsed/refractory Grade 1, 2, or 3a follicular lymphoma (FL), marginal zone lymphoma (MZL), or mantle cell lymphoma (MCL), Stage I to IV, have been previously treated for their lymphoma with at least one prior line of systemic chemotherapy, immunotherapy, or chemoimmunotherapy; have at least one measurable nodal or extranodal lesion by computed axial tomography (CT) or magnetic resonance imaging (MRI) scan, and have adequate bone marrow function, liver function, and renal function.

Subjects with either follicular lymphoma (FL), marginal zone lymphoma (MZL), or mantle cell lymphoma (MCL) will be randomized to Arm A will receive lenalidomide plus rituximab for up to 30 Cycles (12 induction Cycles then 18 maintenance Cycles) followed by lenalidomide single-agent maintenance (to disease progression [PD]).

Subjects with either follicular lymphoma (FL), marginal zone lymphoma (MZL), or mantle cell lymphoma (MCL) will be randomized to Arm B will receive lenalidomide plus rituximab for 12 Cycles (induction) followed by rituximab single-agent for 18 Cycles (maintenance). Cycle length in both arms is 28-days.

Efficacy determination for the primary endpoint will be based upon progression free survival (PFS).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

-- Age ≥18 years

- Histologically confirmed Follicular Lymphoma (Grade 1, 2 or 3a), Marginal Zone Lymphoma, or Mantle Cell Lymphoma

- Must have documented relapsed, refractory or Progressive Disease after last treatment with systemic therapy

- Bi-dimensionally measurable disease

- Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2

- Adequate bone marrow function

- Willingness to follow pregnancy precautions

Exclusion Criteria:

- Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma

- Any medical condition (other than the underlying lymphoma) that requires chronic steroid use

- Subjects taking corticosteroids during the last 1 week prior treatment, unless administered at a dose equivalent to < 20 mg/day of prednisone

- Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 3 months

- Known seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)

- Known sensitivity or allergy to murine products

- Presence or history of central nervous system involvement by lymphoma. Subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it.

- Any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.
Locations
Arizona Oncology
Tucson, Arizona, United States
Status: Recruiting
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
Status: Recruiting
Sutter East Bay Hospitals
Berkeley, California, United States
Status: Recruiting
Sutter Hematology and Oncology
Sacremento, California, United States
Status: Recruiting
Sharp Memorial Hospital
San Diego, California, United States
Status: Recruiting
Rocky Mountain Cancer Centers, LLP [Boulder-COBO]
Boulder, Colorado, United States
Status: Recruiting
Colorado Cancer Research Program
Denver, Colorado, United States
Status: Recruiting
VA Eastern Colorado
Denver, Colorado, United States
Status: Not yet recruiting
VVH Cancer Center Valley View Hospital
Glenwood Springs, Colorado, United States
Status: Recruiting
Whittingham Cancer Center
Norwalk, Connecticut, United States
Status: Recruiting
VVH Cancer Center Valley View Hospital
Boynton Beach, Florida, United States
Status: Recruiting
Cancer Specialists, LLC dba Cancer Specialists of North Florida
Fleming Island, Florida, United States
Status: Recruiting
Florida Cancer Specialists North
Flemming Island, Florida, United States
Status: Recruiting
Baptist Cancer Institute
Jacksonville, Florida, United States
Status: Recruiting
Florida Cancer Specialists North
Jacksonville, Florida, United States
Status: Recruiting
Florida Cancer Affiliates
New Port Richey, Florida, United States
Status: Recruiting
Sacred Heart Medical Oncology Group
Pensacola, Florida, United States
Status: Recruiting
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States
Status: Recruiting
Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute
Marietta, Georgia, United States
Status: Recruiting
Cancer Treatment Centers of America - Southeastern Regional Medical Center
Newnan, Georgia, United States
Status: Recruiting
Alexian Brothers Hospital Network
Elk Grove Village, Illinois, United States
Status: Not yet recruiting
United States Department of Veterans Affairs - VA Great
Hines, Illinois, United States
Status: Recruiting
United States Department of Veterans Affairs - VA Great Lakes Health Care System - Edward Hines Jr
Hines, Illinois, United States
Status: Recruiting
Illinois Cancer Specialists
Niles, Illinois, United States
Status: Recruiting
Oncology Specialists, PC
Park Ridge, Illinois, United States
Status: Recruiting
Oncology Specialists, PC; Lutheran General Cancer Care Center
Park Ridge, Illinois, United States
Status: Recruiting
Oncology Specialists, S.C.
Park Ridge, Illinois, United States
Status: Recruiting
American Health Network of Indiana, LLC
New Albany, Indiana, United States
Status: Recruiting
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Status: Recruiting
University of Kansas Cancer Center
Fairway, Kansas, United States
Status: Recruiting
University of Kansas Cancer Center
Overland Park, Kansas, United States
Status: Not yet recruiting
University of Kansas Cancer Center
Westwood, Kansas, United States
Status: Recruiting
Anne Arundel Medical Center
Annapolis, Maryland, United States
Status: Recruiting
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Status: Recruiting
Associates of Oncology/Hematology, P.C.
Rockville, Maryland, United States
Status: Recruiting
Trinity Health -Michigan, d/b/a Saint Joseph Mercy Health System
Ann Arbor, Michigan, United States
Status: Recruiting
Sparrow Hospital and Health System
Lansing, Michigan, United States
Status: Recruiting
Central Care Cancer Center
Bolivar, Missouri, United States
Status: Recruiting
Mercy Clinic - Cancer & Hematology - Branson
Branson, Missouri, United States
Status: Recruiting
University of Missouri Health Care
Columbia, Missouri, United States
Status: Not yet recruiting
University of Kansas Cancer Center
Kansas City, Missouri, United States
Status: Not yet recruiting
University of Kansas Cancer Center
Kansas City, Missouri, United States
Status: Not yet recruiting
University of Kansas Cancer Center
Lee's Summit, Missouri, United States
Status: Not yet recruiting
Saint Louis University Cancer Center
Saint Louis, Missouri, United States
Status: Recruiting
Mercy Medical Research Institute
Springfield, Missouri, United States
Status: Recruiting
Mercy Medical Research Institute; Mercy Clinic - Cancer & Hematology
Springfield, Missouri, United States
Status: Recruiting
Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States
Status: Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Status: Not yet recruiting
Summit Medical Group/Overlook Oncology Center
Berkeley Heights, New Jersey, United States
Status: Not yet recruiting
Drs. Forte, Schleider, and Attas, P.A.
Englewood, New Jersey, United States
Status: Recruiting
Regional Cancer Care Associates
Mount Holly, New Jersey, United States
Status: Recruiting
Regional Cancer Care Associates LLC
Mount Holly, New Jersey, United States
Status: Recruiting
Brookdale University Hospital and Medical Center
Brooklyn, New York, United States
Status: Recruiting
Broome Oncology, LLC
Johnson City, New York, United States
Status: Recruiting
Kinston Medical Specialists
Kinston, North Carolina, United States
Status: Recruiting
Rex Cancer Center
Raleigh, North Carolina, United States
Status: Recruiting
MetroHealth Medical Systems
Cleveland, Ohio, United States
Status: Recruiting
Mid Ohio Oncology Hematology Inc
Columbus, Ohio, United States
Status: Recruiting
Board of Regents of the University of Oklahoma
Oklahoma City, Oklahoma, United States
Status: Recruiting
Northwest Cancer Specialists, P.C. - Hoyt
Portland, Oregon, United States
Status: Recruiting
Northwest Cancer Specialists, P.C. - North Broadway
Portland, Oregon, United States
Status: Recruiting
Northwest Cancer Specialists, P.C. - SW Barnes
Portland, Oregon, United States
Status: Recruiting
Willamette Valley Cancer Institute
Springfield, Oregon, United States
Status: Recruiting
Northwest Cancer Specialists-Tualatin
Tualatin, Oregon, United States
Status: Recruiting
Hematology and Oncology Associates of SC, LLC
Greenville, South Carolina, United States
Status: Recruiting
Hematology and Oncology Associates of SC, LLC
Greenville, South Carolina, United States
Status: Recruiting
Baptist Cancer Center
Memphis, Tennessee, United States
Status: Recruiting
Baptist Cancer Center
Memphis, Tennessee, United States
Status: Recruiting
Texas Oncology-Arlington South
Arlington, Texas, United States
Status: Recruiting
Texas Health Physicians Group
Dallas, Texas, United States
Status: Recruiting
Texas Health Physicians Group
Dallas, Texas, United States
Status: Recruiting
Texas Oncology
Dallas, Texas, United States
Status: Recruiting
Baylor College of Medicine
Houston, Texas, United States
Status: Not yet recruiting
Michael Debakey VA Medical Center
Houston, Texas, United States
Status: Not yet recruiting
Millenium Oncology
Houston, Texas, United States
Status: Recruiting
Texas Health Physicians Group
Mesquite, Texas, United States
Status: Recruiting
Texas Health Physicians Group
Plano, Texas, United States
Status: Recruiting
Texas Oncology Round Rock Cancer Center - Round Rock
Round Rock, Texas, United States
Status: Recruiting
Cancer Care Centers of South Texas - HOAST
San Antonio, Texas, United States
Status: Recruiting
Cancer Care Network of South Texas - SAT & BC
San Antonio, Texas, United States
Status: Recruiting
Central Texas Veterans Health Care System
Temple, Texas, United States
Status: Not yet recruiting
Tyler Hematology and Oncology
Tyler, Texas, United States
Status: Recruiting
Texas Oncology, P.A. - Deke Slayton Cancer Center
Webster, Texas, United States
Status: Recruiting
Utah Cancer Specialist
Salt Lake City, Utah, United States
Status: Recruiting
Rutland Regional Medical Center
Rutland, Vermont, United States
Status: Recruiting
Oncology and Hematology Associates of Southwest Virginia, Inc. - Market Street
Christiansburg, Virginia, United States
Status: Recruiting
Virginia Oncology Associates
Norfolk, Virginia, United States
Status: Recruiting
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, United States
Status: Recruiting
PeaceHealth St. Joseph Medical Center
Bellingham, Washington, United States
Status: Recruiting
Northwest Medical Specialties PLLC
Gig Harbor, Washington, United States
Status: Recruiting
Northwest Medical Specialties PLLC
Tacoma, Washington, United States
Status: Recruiting
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States
Status: Recruiting
Providence St. Mary Regional Cancer Center
Walla Walla, Washington, United States
Status: Recruiting
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, United States
Status: Recruiting
Yakima Valley Memorial Hospital/ North Star Lodge
Yakima, Washington, United States
Status: Not yet recruiting
West Virginia Research Corporation on behalf of West Virginia University
Morgantown, West Virginia, United States
Status: Recruiting
West Virginia University, Berkeley Medical Center, Cancer and Infusion Center
Morgantown, West Virginia, United States
Status: Recruiting
Aurora Health Care / Aurora Research
Elkhorn, Wisconsin, United States
Status: Recruiting
Aurora Health Care / Aurora Research
Grafton, Wisconsin, United States
Status: Recruiting
Aurora Health Care / Aurora Research
Kenosha, Wisconsin, United States
Status: Recruiting
Aurora Health Care / Aurora Research
Menomonee, Wisconsin, United States
Status: Recruiting
Aurora Health Care / Aurora Research
Milwaukee, Wisconsin, United States
Status: Recruiting
Aurora Health Care / Aurora Research
Milwaukee, Wisconsin, United States
Status: Recruiting
Aurora Health Care / Aurora Research
Milwaukee, Wisconsin, United States
Status: Recruiting
Aurora Health Care / Aurora Research
Racine, Wisconsin, United States
Status: Recruiting
Aurora Health Care / Aurora Research
Waukesha, Wisconsin, United States
Status: Recruiting
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Status: Recruiting
Aurora Health Care / Aurora Research
Wauwatosa, Wisconsin, United States
Status: Recruiting
Aurora Health Care / Aurora Research
West Allis, Wisconsin, United States
Status: Recruiting
Auxilio Mutuo Cancer Center
San Juan, Puerto Rico
Status: Recruiting
Auxilio Mutuo Cancer Center
San Juan, Puerto Rico
Status: Recruiting
Start Date
April 2014
Completion Date
July 2022
Sponsors
Celgene Corporation
Source
Celgene Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page