Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma
Recruiting
Phase 2Interventional Study
Ann Arbor Stage II Follicular LymphomaGrade 1 Follicular LymphomaAnn Arbor Stage III Follicular LymphomaAnn Arbor Stage IV Follicular LymphomaGrade 2 Follicular LymphomaGrade 3a Follicular Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Chinese PLA General Hospital · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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) .
Trial Locations
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Eligibility Criteria
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 …
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, or Night sweats, or 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, or Platelets ≤ 100 x 10\^9/L, or 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.
* ECOG ≤ 2
* ANC \> 1.0 x 10\^9/L (for patients without bone marrow involvement by lymphoma)
* Platelet count \> 50 x 10\^9/L (for patients without bone marrow involvement by lymphoma)
* 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) \< 3 x ULN
* Creatinine clearance \> 30 ml/min calculated by modified Cockcroft-Gault formula
* Bilirubin \< 1.5 x ULN unless bilirubin is due to Gilbert's syndrome, documented liver involvement with lymphoma, or of non-hepatic origin, in which case bilirubin should not exceed 3 g/dL
* Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[B-hCG\]) pregnancy test at screening. Women who are pregnant or breastfeeding are ineligible for this study
Exclusion Criteria:
* Known active central nervous system lymphoma or leptomeningeal disease
* Follicular lymphoma with evidence of diffuse large B-cell transformation
* Grade 3b follicular lymphoma
* Any prior history of other malignancy besides follicular lymphoma
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* Patients who have undergone major surgery within 14 days
* The researchers believe that it is not advisable for the participant to take part in this trial.
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