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Tests treatment safety and results for Relapsed/Refractory Follicular Lymphoma
Official title Efficacy and Safety of Zanubrutinib, Rituximab, and Lenalidomide (ZR²) in Combination With Tislelizumab for Relapsed/Refractory Follicular Lymphoma
ClinicalTrials.gov ID: NCT07418190
What this study is testing
What is tislelizumab + zanubrutinib + rituximab + lenalidomide?
tislelizumab + zanubrutinib + rituximab + lenalidomide is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for relapsed/refractory 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 prospective, open-label, single-arm, single-center, Phase II clinical study designed to evaluate the efficacy and safety of zanubrutinib, rituximab, and lenalidomide (ZR²) in combination with tislelizumab in patients with relapsed/refractory follicular lymphoma who have relapsed or are refractory after ≥1 prior systemic therapy. After successful screening, enrolled patients will receive 6 treatment cycles (21 days per cycle).
- 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 to 75
You may be able to join if
- Eligible participants must meet all of the following criteria:
- Provide written informed consent. Age ≥18 years . Histologically confirmed relapsed/refractory follicular lymphoma (R/R FL) . Received at least two...
- ECOG performance status 0-1 . Measurable disease , with longest diameter \>1.5 cm . Estimated life expectancy (per investigator assessment) ≥18 weeks...
- Adequate hepatic function:
- Total bilirubin ≤1.5 × ULN ; for patients with documented Gilbert syndrome: total bilirubin ≤3 × ULN with predominantly indirect hyperbilirubinemia.
You likely can't join if
- Participants meeting any of the following will be excluded:
- Unable to comply with protocol-required hospitalization and restrictions.
- Active infection or latent tuberculosis infection.
- History of severe hypersensitivity to drugs of the same class.
- Current central nervous system involvement.
- Pregnant or breastfeeding women.
See the full eligibility criteria
- Eligible participants must meet all of the following criteria:
- Provide written informed consent. Age ≥18 years . Histologically confirmed relapsed/refractory follicular lymphoma (R/R FL) . Received at least two prior lines of systemic therapy , including anti-CD20 monoclonal...
- ECOG performance status 0-1 . Measurable disease , with longest diameter \>1.5 cm . Estimated life expectancy (per investigator assessment) ≥18 weeks . Adverse events from prior anticancer therapy must have resolved to...
- Adequate hepatic function:
- Total bilirubin ≤1.5 × ULN ; for patients with documented Gilbert syndrome: total bilirubin ≤3 × ULN with predominantly indirect hyperbilirubinemia.
- AST and ALT ≤3 × ULN .
- Adequate hematologic function:
- ANC ≥1.5 × 10⁹/L (≥1,500/µL) Platelets ≥75,000/µL , with no platelet transfusion within 14 days prior to first dosing on Cycle 1 Day 1 Hemoglobin ≥10.0 g/dL (6.2 mmol/L), with no blood transfusion within 21 days prior...
- For women of childbearing potential: negative serum pregnancy test within 7 days before study treatment; postmenopausal women (non-treatment-related amenorrhea ≥12 months) or surgically sterile women (no ovaries and/or...
- For men: agree to abstinence (avoid heterosexual intercourse) or to use effective contraception.
- Participants meeting any of the following will be excluded:
- Unable to comply with protocol-required hospitalization and restrictions.
- Active infection or latent tuberculosis infection.
- History of severe hypersensitivity to drugs of the same class.
- Current central nervous system involvement.
- Pregnant or breastfeeding women.
- Uncontrolled comorbidities (e.g., cardiac disease, immune disorders); myocardial infarction, unstable arrhythmia, or unstable angina within the past 6 months.
- Illicit drug use or alcohol abuse within 12 months prior to screening, per investigator judgment.
- Any other disease, metabolic disorder, physical examination finding, or clinical laboratory abnormality that reasonably suggests a contraindication to the investigational products.
- The investigator should review vaccination status of potential participants and, prior to study initiation, follow local disease control and prevention guidelines for adult immunization with non-live vaccines aimed at...
- Any psychiatric or cognitive disorder that may limit understanding/execution of informed consent or protocol compliance.
- Pregnant or breastfeeding women, or women/men (or male partners) planning pregnancy during the study period.
- Any other condition deemed by the investigator to make the participant unsuitable for the trial.
- Cases to Be Excluded From Statistical Analysis (per protocol) Participants already enrolled who meet any of the following will be treated as excluded cases in statistical analyses: Post-enrollment discovery of...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, 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.