Combining three medications for untreated follicular lymphoma
Safety and Efficacy of Zanubrutinib in Combination With Rituximab and Venetoclax in Previously Untreated Follicular Lymphoma: An Open Label, Phase 2 Study
This study is testing a new combination of three medications to see if they can effectively treat people with untreated follicular lymphoma without using traditional chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | Rituximab, zanubrutinib, chemotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06471738 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of a treatment regimen combining zanubrutinib, venetoclax, and rituximab in patients with previously untreated follicular lymphoma. It is a single-center, open-label, single-arm phase II trial aimed at assessing a chemotherapy-free approach to treating this common type of non-Hodgkin's lymphoma. The study focuses on patients with advanced stages of follicular lymphoma who exhibit specific symptoms indicating the need for therapy. By avoiding traditional chemotherapy, the trial seeks to reduce toxicity while maintaining treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with untreated follicular lymphoma at stages II, III, or IV who exhibit symptoms necessitating therapy.
Not a fit: Patients with previously treated follicular lymphoma or those not exhibiting significant symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less toxic and effective option for patients with follicular lymphoma.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using targeted therapies for lymphoma, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing
- Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Yang Liu, Md
- Email: liuyang301blood@163.com
- Phone: 010-66937463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.