Treatment of CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma With Bruton Tyrosine … (NCT05068440) | Clinical Trial Compass
CompletedPhase 2
Treatment of CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma With Bruton Tyrosine Kinase Inhibitor Zanubrutinib
China65 participantsStarted 2021-08-11
Plain-language summary
The goal of this clinical trial was to evaluate whether zanubrutinib can effectively treat adults with CD79B-mutant relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Participants received zanubrutinib as monotherapy, underwent regular disease assessments to evaluate treatment response, and were monitored for safety and side effects throughout the study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants had histologically confirmed diffuse large B-cell lymphoma, based on the World Health Organization 2008 classification of tumors of hematopoietic and lymphoid tissue.
✓. Participants had a positive CD79B gene mutation, as confirmed by a central laboratory.
✓. Participants had previously received at least one line of adequate systemic therapy for diffuse large B-cell lymphoma, defined as anti-CD20 antibody-based chemoimmunotherapy administered for at least two consecutive cycles, unless disease progression occurred before completion of Cycle 2.
✓. Participants had relapsed or refractory disease prior to study entry, defined as either:
✓. Recurrent disease after achieving disease remission, defined as a complete response or partial response, at the completion of the most recent treatment regimen; or
✓. Stable disease or progressive disease at the completion of the most recent treatment regimen.
✓. Participants were ineligible for high-dose therapy and stem cell transplantation, defined as meeting at least one of the following criteria:
✓. Left ventricular ejection fraction less than 50 percent as measured by echocardiogram or multiple gated acquisition scan;
Exclusion criteria
✕. Participants had non-Hodgkin lymphoma other than classical histology diffuse large B-cell lymphoma (not otherwise specified), including but not limited to:
✕. Diffuse large B-cell lymphoma transformed from indolent lymphomas
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: Response was assessed every 12 weeks for the first 24 months and every 24 weeks thereafter. Maximum time on study was 36.4 months