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New treatment option for Ann Arbor Stage II Follicular Lymphoma
Official title Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma
ClinicalTrials.gov ID: NCT06471738
What this study is testing
What is Zanubrutinib?
Zanubrutinib is an investigational medicine, being studied as a potential treatment for ann arbor stage ii follicular lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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) .
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.