Combining three medications for untreated follicular lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tafasitamab and Rituximab for newly diagnosed follicular lymphoma

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• Combining acalabrutinib and obinutuzumab to treat untreated follicular lymphoma and indolent non-Hodgkin lymphomas

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• Polatuzumab vedotin with Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in untreated DLBCL (MCD/BN2/N1)

  This study tests a targeted combination therapy to see if it can treat previously untreated DLBCL with specific molecular subtypes.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07608978

• Zanubrutinib, rituximab, lenalidomide plus tislelizumab for relapsed/refractory follicular lymphoma

  This trial tests whether adding the PD‑1 blocker tislelizumab to zanubrutinib, rituximab, and lenalidomide helps adults with relapsed or refractory follicular lymphoma who have had at least two prior therapies.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07418190

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.