NCT06136351 A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma
| NCT ID | NCT06136351 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ruijin Hospital |
| Condition | Lymphoma, Mantle-Cell |
| Study Type | INTERVENTIONAL |
| Enrollment | 23 participants |
| Start Date | 2023-11-15 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 23 participants in total. It began in 2023-11-15 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Zanubrutinib given in combination with bendamustine and rituximab in (elderly or TP53 alterations or chemotherapy intolerance) patients with newly diagnosed mantle cell lymphoma.
Eligibility Criteria
Inclusion Criteria: * 18 years * Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO) * FISH with del(17p)/TP53 mutation or ≥65 years; or\<65 years but chemotherapy intolerance; * Life expectancy of \> 3 months (in the opinion of the investigator); * Creatinine Clearance Rate (CCR) ≥ 50 mL/min or estimated Glomerular Filtration ●Rate (eGFR) ≥ 60 mL/(min·1.73 m\^2); * International Normalized Ratio (INR) ≤ 1.5 and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 times the upper limit of normal; * Left Ventricular Ejection Fraction (LVEF) ≥ 50%; * Agreeing to provide written informed consent prior to any special examination or procedure for the research on their own or legal representative. Exclusion Criteria: * Pregnant or lactating women; * Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA \> detectable limit); * With acquired or congenital immunodeficiency; * With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF \< 50%; * Known to be allergic to the test drug ingredients; * Diagnosed with or being treated for malignancy other than lymphoma; * With severe infection; * Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results; * Deemed unsuitable for the group.
Frequently Asked Questions
Who can join the NCT06136351 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphoma, Mantle-Cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06136351 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06136351 currently recruiting?
Yes, NCT06136351 is actively recruiting participants. Visit ClinicalTrials.gov or contact Ruijin Hospital to inquire about joining.
Where is the NCT06136351 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06136351 clinical trial?
NCT06136351 is sponsored by Ruijin Hospital. The trial plans to enroll 23 participants.