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
- Sponsor
- Ruijin Hospital
- Study ID
- NCT06136351
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Lymphoma, Mantle-Cell
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Zanubrutinib — DRUG160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 2 years of follow-up
- Rituximab — DRUG375 mg/m\^2 ivgtt, D0 of each 28-day cycle
- Bendamustin — DRUG90mg/m\^2 ivgtt, D0 of each 28-day cycle
Study Details
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.
Key Dates
- Start date
- Nov 15, 2023
- Status verified
- Nov 2023
- Primary completion
- Nov 1, 2027
- Completion
- Nov 1, 2027
Study Design
- Enrollment
- 23 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ZBR
Primary Outcome Measure
2-year Progression-Free Survival [ Time Frame: 2 years ]