RECRUITING

A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

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Conditions

Relapsed/Refractory Follicular LymphomaMarginal Zone LymphomaZanubrutinibBGB-3111RituximabLenalidomideObinutuzumab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R\^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron emission tomography and computed tomography (PET/CT), and to compare the efficacy of zanubrutinib plus rituximab versus R\^2 in participants with R/R marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria.

Official Title

A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

Quick Facts

Study Start:2022-03-10
Study Completion:2030-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05100862

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed grade 1-3a FL or MZL
  2. * Previously treated with ≥ 1 line of systemic therapy including anti-CD20 agent. Must have a documented failure to achieve at least partial response during the most recent systemic therapy or documented progressive disease after the most recent systemic therapy
  3. * Need for systemic therapy for FL or MZL
  4. * Measurable disease by computed tomography or magnetic resonance imaging
  5. * Adequate bone marrow, liver and renal function
  1. * Transformation to aggressive lymphoma
  2. * Requiring ongoing need for corticosteroid treatment
  3. * Clinically significant cardiovascular disease
  4. * Prior malignancy within the past 2 years
  5. * Active fungal, bacterial, and/or viral infection that requires systemic therapy
  6. * Prior treatment with lenalidomide or drug from same class, if without response (partial or complete) or short remission duration (\< 24 months)

Contacts and Locations

Study Contact

Study Director BeiGene
CONTACT
1-877-828-5568
clinicaltrials@beigene.com

Principal Investigator

Study Director
STUDY_DIRECTOR
BeiGene
Study Director
PRINCIPAL_INVESTIGATOR
BeiGene

Study Locations (Sites)

Ucsf Fresno University of California San Francisco Fresno
Fresno, California, 93730
United States
Kaiser Permanente Southern California
Irvine, California, 92618
United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
United States
Los Angeles Cancer Network
Los Angeles, California, 90017
United States
Valkyrie Clinical Trials
Los Angeles, California, 90067
United States
UCLA Hematologyoncology
Los Angeles, California, 90095
United States
Scripps Health
San Diego, California, 92103
United States
Sharp Healthcare Sharp Memorial Hospital
San Diego, California, 92123
United States
Baptist Md Anderson Cancer Center
Jacksonville, Florida, 32207
United States
Memorial Cancer Institute, Memorial Healthcare System
Pembroke Pines, Florida, 33026
United States
Ascension Sacred Heart
Pensacola, Florida, 32504
United States
Northwest Georgia Oncology Centers Marietta
Marietta, Georgia, 30060
United States
Cancer Care Specialists of Illinois
Decatur, Illinois, 62526
United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
United States
Mission Cancer and Blood
Des Moines, Iowa, 50309
United States
Cotton Oneil Cancer Center
Topeka, Kansas, 66606
United States
Cancer Center of Kansas
Wichita, Kansas, 67214
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
Christus Highland Cancer Treatment Center
Shreveport, Louisiana, 71105
United States
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, 21401
United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
United States
Ascension St Agnes Hospital
Baltimore, Maryland, 21229
United States
American Oncology Partners of Maryland Pa
Bethesda, Maryland, 20817
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Corewell Health the Michigan Cancer Consortium
Grand Rapids, Michigan, 49503
United States
Ascension St John Hospital
Grosse Pointe Woods, Michigan, 48236
United States
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, 39401
United States
University of Missouri Hospital, Ellis Fischel Cancer Center
Columbia, Missouri, 65212
United States
Oncology Hematology Associates
Springfield, Missouri, 65807
United States
St Vincent Frontier Cancer Center
Billings, Montana, 59102
United States
Nebraska Cancer Specialists (Satellite Site)
Grand Island, Nebraska, 68803
United States
Nebraska Cancer Specialists
Grand Island, Nebraska, 68803
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
United States
Iyengar Hematology Oncology Medical Center Pa
Bayonne, New Jersey, 07002
United States
Summit Medical Group
Florham Park, New Jersey, 07932
United States
North Shore Hematology Oncology Associates Eccc Bronx
Bronx, New York, 10469
United States
New York Cancer and Blood Specialists
East Setauket, New York, 11733
United States
North Shore Hematology Oncology Associates New Hyde Park
New Hyde Park, New York, 10028
United States
North Shore Hematology Oncology Associates Dba New York Cancer and Blood Specialists (New York)
New York, New York, 10028
United States
Suny Upstate Medical University
Syracuse, New York, 13210
United States
Clinical Research Alliance, Inc
Westbury, New York, 11590
United States
Levine Cancer Institute Wake Forest
Charlotte, North Carolina, 28204
United States
Oncology Hematology Care Clinical Trials, Llc
Cincinnati, Ohio, 45245
United States
Va Northeast Ohio Healthcare System
Cleveland, Ohio, 44106
United States
Toledo Clinic Cancer Center
Toledo, Ohio, 43623
United States
Mainline Health Lankenau Institute For Medical Research
Wynnewood, Pennsylvania, 19096
United States
Cancer Care Associates of York
York, Pennsylvania, 17403
United States
Prairie Lakes Healthcare System
Watertown, South Dakota, 57201
United States
Texas Oncology Baylorcharles A Sammons Cancer Center
Dallas, Texas, 75246
United States
Md Anderson Cancer Center
Houston, Texas, 77030
United States
Texas Oncology Longview Cancer Center
Longview, Texas, 75601
United States
Texas Oncology Palestine Cancer Center
Palestine, Texas, 75801
United States
Texas Oncology Paris
Paris, Texas, 75460
United States
Northeast Texas Cancer and Research Institute
Tyler, Texas, 75702
United States
Northwest Medical Specialties
Puyallup, Washington, 98373
United States
University of Washington
Seattle, Washington, 98195
United States
Medical Oncology Associates
Spokane, Washington, 99208
United States
Wvu Medicine, Wheeling Hospital
Wheeling, West Virginia, 26003
United States

Collaborators and Investigators

Sponsor: BeiGene

  • Study Director, STUDY_DIRECTOR, BeiGene
  • Study Director, PRINCIPAL_INVESTIGATOR, BeiGene

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-10
Study Completion Date2030-06

Study Record Updates

Study Start Date2022-03-10
Study Completion Date2030-06

Terms related to this study

Keywords Provided by Researchers

  • Zanubrutinib
  • BGB-3111
  • Rituximab
  • Lenalidomide
  • Obinutuzumab

Additional Relevant MeSH Terms

  • Relapsed/Refractory Follicular Lymphoma
  • Marginal Zone Lymphoma