Orelabrutinib Combined With Rituximab and Chemotherapy for Relapsed/Refractory B-Cell Lymphoma Patients With Central Nervous System Involvement

Sponsor
Ruijin Hospital
Study ID
NCT05926427
Phase
PHASE2
Status
Unknown

Conditions

  • CNS Lymphoma

Eligibility Criteria

Sex
ALL
Age
14 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Orelabrutinib — DRUG
    150 mg qd po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during 2 years of follow-up
  • Rituximab — DRUG
    375 mg/m\^2 ivgtt, D0 of each 28-day cycle
  • Chemotherapy — DRUG
    Not specified, recommended regimen according to histopathologic type

Study Details

This single-center, open, single-arm study aim to evaluate the efficacy and tolerability of a therapy introducing orelabrutinib on the basis of rituximab and chemotherapy in treating patients with relapsed or refractory B-cell lymphoma invloving central nervous system.

Key Dates

Start date
Aug 10, 2023
Status verified
Sep 2023
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OR-chemo
    Drug: Orelabrutinib, Rituximab and recommended chemotherapy according to histopathologic type

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: At the end-of-therapy response evaluation, 6 weeks after the end of Cycle 6, each cycle lasting 4 weeks ]

Central Contacts

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