A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma

  • STATUS
    Recruiting
  • End date
    Nov 24, 2023
  • participants needed
    210
  • sponsor
    BeiGene
Updated on 24 June 2021
Investigator
Eric Hedrick, MD
Primary Contact
Tula Area Clinical Hospital (0.0 mi away) Contact
+179 other location

Summary

The purpose of the study is to evaluate the efficacy, safety and tolerability and of BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma.

Details
Condition Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, Relapsed/Refractory Follicular Non-Hodgkin Lymphoma
Treatment Obinutuzumab, BGB-3111, Zanubrutinib
Clinical Study IdentifierNCT03332017
SponsorBeiGene
Last Modified on24 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clinically significant cardiovascular disease
Major surgery or significant injury 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
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