A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular … (NCT03332017) | Clinical Trial Compass
CompletedPhase 2
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
United States, Australia217 participantsStarted 2017-11-14
Plain-language summary
This clinical study examined the safety and efficacy of the combination of zanubrutinib and obinutuzumab versus obinutuzumab alone in adults with follicular lymphoma whose disease returned after or did not respond to prior therapy.
Who can participate
Age range18 Years
SexALL
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Key Inclusion Criteria:
* Participants had a histologically confirmed diagnosis of B-cell follicular lymphoma.
* Participants had received two or more prior systemic treatments for follicular lymphoma.
* Participants had previously received both an anti-cluster of differentiation 20 (anti-CD20) antibody and an appropriate alkylator-based combination therapy.
* Participants had disease that had progressed after completion of the most recent therapy or was considered refractory to treatment.
* Participants had measurable disease present.
* Archival tissue confirming the diagnosis was available.
* Participants had an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Participants had adequate renal and hepatic function.
Key Exclusion Criteria:
* Participants had prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.
* Participants had known central nervous system involvement by leukemia or lymphoma.
* Participants had evidence of transformation from follicular lymphoma to another aggressive histologic subtype.
* Participants had undergone an allogeneic hematopoietic stem cell transplantation within 12 months of enrollment.
* Participants had a prior malignancy within the past 2 years, except for those who had curatively treated basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized prostate cancer with a Gleason score of 6.
* Participants had clinically significant cardiova…
What they're measuring
1
Overall Response Rate (ORR) by Independent Central Review (ICR) Assessment
Timeframe: From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.