Status:
COMPLETED
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
Lead Sponsor:
BeiGene
Conditions:
Relapsed/Refractory Follicular Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
he purpose of the study is to evaluate the efficacy, safety, and tolerability BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymph...
Eligibility Criteria
Inclusion
- Key
- Histologically confirmed diagnosis of B-cell follicular lymphoma
- ≥2 prior systemic treatments for follicular lymphoma.
- Previously received an anti-CD20 antibody and an appropriate alkylator-based combination therapy.
- Disease progression after completion of most recent therapy or refractory disease.
- Presence of measurable disease.
- Availability of archival tissue confirming diagnosis.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
- Adequate renal and hepatic function.
- Key
Exclusion
- Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.
- Known central nervous system involvement by leukemia or lymphoma.
- Evidence of transformation from follicular lymphoma to other aggressive histology.
- Allogeneic hematopoietic stem cell transplantation within 12 months of enrollment
- Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix of breast, or localized Gleason score 6 prostate cancer.
- Clinically significant cardiovascular disease.
- Major surgery ≤ 4 weeks prior to start of study treatment.
- Active fungal, bacterial or viral infection requiring systemic treatment.
- History of severe bleeding disorder.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
November 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2024
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT03332017
Start Date
November 14 2017
End Date
December 27 2024
Last Update
January 23 2025
Active Locations (89)
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1
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
2
University of Illinois At Chicago
Chicago, Illinois, United States, 60612
3
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
4
Duke University
Durham, North Carolina, United States, 27710