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Two drugs, lenalidomide and rituximab, alone or with the drug tazemetostat to treat follicular lymphoma that has come back (relapsed) or has not gotten better with treatment (refractory)

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18 and older

Phase 3

76 Locations

NCT04224493

Clinical Trial Goal


To find out if the combination of lenalidomide, rituximab and tazemetostat is safe and works well to treat follicular lymphoma that has relapsed or is refractory compared to lenalidomide and rituximab alone

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have follicular lymphoma that has relapsed or is refractory
  • Doctors consider the lymphoma grade 1, 2 or 3a
  • Have not been treated with lenalidomide. Your doctor can tell you this
  • Have not been treated with tazemetostat or other EZH2 inhibitors. Your doctor can tell you this
  • Do not have untreated lymphoma in your brain or spinal cord
  • You agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Lenalidomide is a drug that blocks growth of cancer cells.
Rituximab is a monoclonal antibody that targets CD20 on certain cells.
Tazemetostat is a small molecule inhibitor that blocks EZH2 in certain cells.

In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
  • Group 1Lenalidomide, rituximab plus tazemetostat
  • Group 2Lenalidomide, rituximab plus placebo

Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You and the clinical trial doctors won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.

You’ll get:
  • Lenalidomide – A pill that you take by mouth 1 time each day for the first 3 weeks of each month for 1 year
  • Rituximab – Given as intravenous (IV) infusions 1 time each week for 4 months
  • Tazemetostat (Group 1 only) – A pill that you take by mouth 2 times each day for 1 year
  • Placebo (Group 2 only) – A pill with no medicine in it that you take by mouth 2 times each day for 1 year

You’ll have scans to see how well treatment is working. The clinical trial doctors will check your health for up to 8 years.

The Food and Drug Administration (FDA) has approved all of the drugs in this trial to treat follicular lymphoma. Using them together in this way to treat follicular lymphoma that has relapsed or is refractory is new and unproven.

Contacts


Ipsen Clinical Study Enquiries, See e mail, clinical.trials@ipsen.com

Locations

Southern Cancer CenterRECRUITING

Mobile, Alabama
Michael Meshad, MD

Arizona Oncology Associates - Tuscon-Rusadill RoadRECRUITING

Tucson, Arizona
Sudhir Manda, MD

TOI - Clinical ResearchRECRUITING

Cerritos, California

UCLA Clinical Research Unit Hematology/OncologyRECRUITING

Santa Monica, California
Sven De Vos, MD

UC San Diego Health SciencesRECRUITING

La Jolla, California
Benjamin Heyman

UCSF FresnoRECRUITING

Clovis, California
Haifaa Abdulhaq, MD

Rocky Mountain Cancer Centers (RMCC) - BoulderRECRUITING

Boulder, Colorado
David Andorsky, MD

St. Mary's Hospital and Regional Medical Center - St. Mary'sRECRUITING

Grand Junction, Colorado
Kyle Work, MD

SCL Health Lutheran Medical CenterWITHDRAWN

Greeley, Colorado

BRCR Medical Center, INCRECRUITING

Plantation, Florida
Jason Tache, MD

Cancer Specialists of North FloridaRECRUITING

Fleming Island, Florida
Mehdi M Moezi, MD

Florida Cancer Affiliates/Ocala Oncology - ClinicRECRUITING

Ocala, Florida
Ketan Doshi, MD

Florida Cancer SpecialistsRECRUITING

St. Petersburg, Florida
Sunil Gandhi, MD

Florida Cancer Specialists - PanhandleRECRUITING

Tallahassee, Florida

Florida Cancer Specialists & Research Institute (FCS) - AtlantisRECRUITING

West Palm Beach, Florida
Shachar Peles, MD

H Lee Moffitt Cancer Center and Research Institute IRECRUITING

Tampa, Florida
Sameh Gaballa, MD

Mayo ClinicRECRUITING

Jacksonville, Florida
Tan Han, MD

Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer CenterTERMINATED

Fort Myers, Florida

Mayo Clinic - Cancer Clinical Research OfficeWITHDRAWN

Jacksonville, Florida

Miami Cancer InstituteWITHDRAWN

Miami, Florida

Kaiser Permanente Hawaii Moanalua Medical CenterWITHDRAWN

Honolulu, Hawaii

Illinois Cancer SpecialistsRECRUITING

Niles, Illinois
Leonard Klein, MD

University of ChicagoRECRUITING

Chicago, Illinois
Sonali Smith, MD

June E. Nylen Cancer CenterWITHDRAWN

Sioux City, Iowa

The University of Kansas Cancer CenterWITHDRAWN

Overland Park, Kansas

The office of Frederick P. Smith, MD, P.C.WITHDRAWN

Chevy Chase, Maryland

University of MarylandWITHDRAWN

Baltimore, Maryland

Mass General Cancer Center at Newton-WellesleyWITHDRAWN

Newton, Massachusetts

St. Joseph Mercy HospitalRECRUITING

Ypsilanti, Michigan
Christopher Reynolds, MD

University of Michigan Comprehensive Cancer CenterRECRUITING

Ann Arbor, Michigan
Sano Dahlia, MD

Mayo Clinic - RochesterRECRUITING

Rochester, Minnesota
Jose C Villasboas Bisneto, MD

Saint Louis University Cancer CenterWITHDRAWN

St Louis, Missouri

University Of Nebraska Medical CenterRECRUITING

Omaha, Nebraska
Julie Vose, MD

Astera Cancer CareRECRUITING

East Brunswick, New Jersey
Bruno Fang, MD

Astera Cancer CenterRECRUITING

East Brunswick, New Jersey
Bruno Fang, MD

Regional Cancer Care Associates-FreeholdRECRUITING

Freehold, New Jersey
Nandini Ignatius, MD

Regional Cancer Care Associates LLC - Little SilverRECRUITING

Little Silver, New Jersey
Ian Horkheimer, MD

Hackensack University Medical John Theurer Cancer CenterWITHDRAWN

Hackensack, New Jersey

Regional Cancer Care Associates LLC - HowellWITHDRAWN

Howell Township, New Jersey

New Mexico Cancer Care AllianceRECRUITING

Albuquerque, New Mexico
Leslie Andritsos, MD

Columbia U - Herbert Irving Comprehensive Cancer CenterRECRUITING

New York, New York
Jennifer Amengual, MD

Hematology Oncology Associates of Rockland, P.C.RECRUITING

Nyack, New York
Sung Ho Lee, MD

Memorial Sloan-Kettering Cancer CenterRECRUITING

New York, New York

Weill Cornell Medicine-New York Presbyterian HospitalRECRUITING

New York, New York
John P Leonard, MD

New York Oncology Hematology, P.C.WITHDRAWN

Albany, New York

Northwell Health/Monter Cancer CenterWITHDRAWN

Lake Success, New York

FirstHealth of the CarolinasRECRUITING

Pinehurst, North Carolina
Charles Kuzma, MD

Levine Cancer Institute - ConcordRECRUITING

Concord, North Carolina

Messino Cancer CenterRECRUITING

Asheville, North Carolina
Christopher Chay, MD

Gabrail Cancer Center ResearchRECRUITING

Canton, Ohio
Nashat Gabrail, MD

Oncology Hematology Care (OHC), Inc. - Kenwood OfficeRECRUITING

Cincinnati, Ohio
Miguel Islas-Ohlmayer, MD

Willamette Valley Cancer Institute and Research Center - OncologyRECRUITING

Eugene, Oregon
Jeffrey Sharman, MD

Western Pennsylvania Hospital Hematology & Cellular TherapyRECRUITING

Pittsburgh, Pennsylvania

University of Pittsburgh Medical Center - OncologyWITHDRAWN

Pittsburgh, Pennsylvania

Sarah Cannon Research InstituteRECRUITING

Nashville, Tennessee
Viralkumar Bhanderi, MD

Tennessee Oncology, PLLCWITHDRAWN

Chattanooga, Tennessee

University of Tennessee Medical Center - Cancer InstituteWITHDRAWN

Knoxville, Tennessee

Mays Cancer CenterRECRUITING

San Antonio, Texas
Adolfo Diaz Duque, MD

Millennium Physicians - OncologyRECRUITING

Houston, Texas
Charles Yen, MD

Texas OncologyRECRUITING

Plano, Texas
Charles Connor, MD

Texas Oncology - AmarilloRECRUITING

Amarillo, Texas
Praveen Tumula, MD

Texas Oncology-Austin MidtownRECRUITING

Austin, Texas
Jason M Melear, MD

Texas Oncology-Baylor Charles A. Sammons Cancer CenterRECRUITING

Dallas, Texas
Moshe Y Levy, MD

Texas Oncology - Medical City Dallas Pediatric HematologyRECRUITING

Dallas, Texas
Jay Courtright, MD

Texas Oncology- WeslacoRECRUITING

Weslaco, Texas
Daniel Farray-Berges, MD

The University of Texas MD Anderson Cancer CenterRECRUITING

Houston, Texas

USO Texas Oncology - TylerRECRUITING

Tyler, Texas
Habte A Yimer, MD

UT Health East Texas HOPE Cancer Center - TylerRECRUITING

Tyler, Texas
Arielle S Lee, MD

Huntsman Cancer Institute; The University of UtahRECRUITING

Salt Lake City, Utah
Harsh Shah, MD

Utah Cancer Specialists/ IHO CorpRECRUITING

Salt Lake City, Utah
Stephan Kendall, MD

Oncology and Hematology Associates of Southwest Virginia Inc.RECRUITING

Roanoke, Virginia
Amanda Gillespie-Twardy, MD

Virginia Cancer SpecialistsRECRUITING

Gainesville, Virginia
Mitul Gandhi, MD

Peninsula Cancer InstituteWITHDRAWN

Chesapeake, Virginia

MC Rockwood Cancer Bl Specialty Ctr - NorthWITHDRAWN

Spokane, Washington

Yakima Valley Memorial Hospital - North Star Lodge Cancer CenterWITHDRAWN

Yakima, Washington

Wheeling HospitalRECRUITING

Wheeling, West Virginia

ClinicalTrials.gov record


NCT04224493. First posted on 1/13/20

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