Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06471738

Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma

Led by Chinese PLA General Hospital · Updated on 2024-07-18

30

Participants Needed

1

Research Sites

150 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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) .

CONDITIONS

Official Title

Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with untreated follicular lymphoma grades 1, 2, or 3a
  • Stage II, III, or IV disease
  • Able and willing to provide written informed consent and comply with the study protocol
  • At least one measurable disease
  • Requires therapy as shown by one or more of the following: presence of B symptoms (fever > 38°C not due to infection, night sweats, weight loss > 10% in 6 months), fatigue from lymphoma, splenomegaly > 13 cm, compression syndrome, lymphoma-related cytopenias (hemoglobin 64 10 g/dL, platelets 64 100 x 10^9/L, ANC < 1.5 x 10^9/L), pleural or peritoneal effusion, elevated LDH or beta-2 microglobulin, or other lymphoma symptoms as judged by the physician
Not Eligible

You will not qualify if you...

  • ECOG performance status greater than 2
  • Absolute neutrophil count (ANC) less than or equal to 1.0 x 10^9/L
  • Platelet count less than or equal to 50 x 10^9/L
  • Prothrombin time (PT)/INR greater than or equal to 1.5 x ULN or aPTT greater than or equal to 1.5 x ULN (unless unrelated to bleeding disorders); if on warfarin or vitamin K antagonists, INR must be 3.0 or less
  • Serum AST and ALT greater than or equal to 3 x ULN
  • Creatinine clearance less than or equal to 30 ml/min
  • Bilirubin greater than or equal to 1.5 x ULN unless due to Gilbert's syndrome, liver lymphoma involvement, or non-hepatic cause (bilirubin must not exceed 3 g/dL in those cases)
  • Women who are pregnant or breastfeeding, or women of childbearing potential without a negative pregnancy test
  • Known active central nervous system lymphoma or leptomeningeal disease
  • Follicular lymphoma with diffuse large B-cell transformation
  • Grade 3b follicular lymphoma
  • Prior history of other malignancies besides follicular lymphoma
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
  • Major surgery within 14 days before screening
  • Any condition that makes participation inadvisable according to the researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital

Beijing, China, 100853

Actively Recruiting

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Research Team

Y

YANG LIU, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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