Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Folli⦠(NCT06471738) | Clinical Trial Compass
RecruitingPhase 2
Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma
China30 participantsStarted 2024-07-10
Plain-language summary
This is a single center, open label, single arm phase II clinical trial. The objective of this study is to assess the feasibility and efficacy of zanubrutinib combined with venetoclax and Rituximab in patients with previously untreated follicular lymphoma (FL) .
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* A diagnosis of follicular lymphoma (grades 1, 2, or 3a), untreated
* Stage II, III, or IV disease
* Able and willing to provide written informed consent and to comply with the study protocol
* at least one measurable disease
* Must be in need of therapy as evidenced by at least one of the following criteria:
* Presence of at least one B symptom:
* Fever (\> 38 Celsius \[C\]) not due to infectious etiology
* Night sweats
* Weight loss \> 10% in the past 6 months
* Fatigue due to lymphoma
* Splenomegaly (\> 13 cm)
* Compression syndrome (ureteral, orbital, gastrointestinal)
* Any of the following cytopenias, due to lymphoma:
* Hemoglobin ⤠10 g/dL
* Platelets ⤠100 x 10\^9/L
* Absolute neutrophil count (ANC) \< 1.5 x 10\^9/L
* Pleural or peritoneal effusion
* Lactate dehydrogenase (LDH) \> upper limit of normal (ULN) or beta (B)2 microglobulin \> ULN
* Other lymphoma-mediated symptoms as determined by the treating physician
Exclusion Criteria:
* ECOG⤠2
* Absolute neutrophil count (ANC) \> 1.0 x 10\^9/L
* Platelet count \> 50 x 10\^9/L
* Prothrombin time (PT)/international normal ratio (INR) \< 1.5 x (upper limit of normal) ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time \[aPTT\]) \< 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder). When treated with warfarin or other vitamin K antagonists, then INR ⤠3.0)
* Serum aspartate transaminase (AST) and alanine transaminase (ALT)ā¦