Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment

Sponsor
Ruijin Hospital
Study ID
NCT06496308
Phase
PHASE3
Status
Recruiting
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Conditions

  • Mantle Cell Lymphoma (MCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Orelabrutinib — DRUG
    Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
  • Bendamustine — DRUG
    Bendamustine IV will be administered as per the schedule specified in the respective arm.
  • Rituximab — DRUG
    Rituximab IV will be administered as per the schedule specified in the respective arm.
  • Venetoclax — DRUG
    Venetoclax PO will be administered as per the schedule specified in the respective arm.

Study Details

This multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab (OBR) versus Bendamustine and Rituximab (BR) in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who are ineligible for transplantation. The primary objective is to assess the complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.

Key Dates

Start date
Jul 10, 2024
Status verified
Jul 2024
Primary completion
Jul 10, 2027
Completion
Jul 10, 2027

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Orelabrutinib + Bendamustine + Rituximab (OBR)
    In induction phase, patients will be randomized in two groups, one is OBR and another is BR. Patients in OBR group will receive rituximab 375 mg/m² IV on day 1, bendamustine 90 mg/m² IV on day 1 and 2, and orelabrutinib 150mg/day PO once daily, every 28 day per cycle for 6 cycles.
  • Placebo Comparator: Bendamustine + Rituximab (BR)
    In induction phase, patients will be randomized in two groups, one is OBR and another is BR. Patients in BR group will receive rituximab 375 mg/m² IV on day 1, bendamustine 90 mg/m² IV on day 1 and 2, every 28 day per cycle for 6 cycles.
  • Other: Orelabrutinib + Venetoclax (OV)
    In maintanance phase, patients will receive different medical regimen according to their TP53 mutation and blastic and pleomorphic variants status. Patients with TP53 mutation or blastic and/or pleomorphic variant will receive orelabrutinib 150mg/day PO once daily and venetoclax for up to 2 years, the dosing of Venetoclax is escalated gradually to reach a target dose of 400 mg.
  • Other: Orelabrutinib (O)
    In maintanance phase, patients will receive different medical regimen according to their TP53 mutation and blastic and pleomorphic variants status. Patients without TP53 mutation or blastic and/or pleomorphic variant will receive orelabrutinib 150mg/day PO once daily for up to 2 years.

Primary Outcome Measure

Complete response rate [ Time Frame: End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days] ]

Central Contacts

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