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

Launched by CHINESE PLA GENERAL HOSPITAL · Jun 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a combination of three medications—zanubrutinib, rituximab, and venetoclax—aimed at treating patients with previously untreated follicular lymphoma, a type of blood cancer. The researchers want to see how well these drugs work together and if they can help patients feel better. The trial is open to adults aged 65 and older who have been diagnosed with follicular lymphoma that hasn't been treated yet and shows certain symptoms, such as significant weight loss, fever, or fatigue.

If you or a loved one are considering participating, you would need to meet specific criteria, including having a measurable form of the disease and experiencing symptoms that indicate a need for treatment. Participants can expect to receive the combination therapy and will be monitored for its effectiveness and any side effects. It's important to note that individuals with certain health issues or recent surgeries may not be eligible for this trial. This study is currently recruiting participants, so there is an opportunity to contribute to research that may improve treatment for others in the future.

Gender

ALL

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 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) \< 3 x upper limit of normal (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.