Optimize Study - Orelabrutinib Combined With BR/G in Untreated Marginal Zone Lymphoma (MZL)

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT06504940
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Marginal Zone Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Orelabrutinib combined with bendamustine and rituximab — DRUG
    they will receive three cycles of Orelabrutinib combined with bendamustine and rituximab (BR: bendamustine 70mg/m\^2 on days 1-2; rituximab 375mg/m\^2 on day 0). Patients achieving PR or better will enter the Orelabrutinib monotherapy maintenance phase (up to 21 cycles, each cycle 28 days).
  • Orelabrutinib combined with obinutuzumab — DRUG
    they will receive six cycles of Orelabrutinib combined with obinutuzumab (G 1000mg iv on days 1, 8, 15 of cycle 1, and day 1 of cycles 2-6; Orelabrutinib 150mg once daily). Patients achieving PR or better will enter the Orelabrutinib monotherapy maintenance phase (up to 18 cycles, each cycle 28 days ).

Study Details

This is a multi-center, prospective cohort study. The main purpose of Cohort A is to evaluate the efficacy and safety of Orelabrutinib combined with BR (bendamustine and rituximab) for previously untreated young patients with MZL; the purpose of Cohort B is to assess the efficacy and safety of Orelabrutinib combined with G (Obinutuzumab) followed by Orelabrutinib maintenance therapy for previously untreated elderly patients with MZL.

Key Dates

Start date
Jun 28, 2024
Status verified
Jul 2025
Primary completion
Jul 8, 2027
Completion
Jul 8, 2029

Study Design

Enrollment
69 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    For individuals under 70 years of age with good fitness,
  • Experimental: Cohort B
    For individuals aged 70 or older or those under 70 years with poor fitness

Primary Outcome Measure

Cohort A:the complete response rate (CRR) [ Time Frame: At 3 months. ]

Central Contacts

Related Studies