A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL

Sponsor
InnoCare Pharma Inc.
Study ID
NCT06363994
Phase
PHASE3
Status
Recruiting
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Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Orelabrutinib — DRUG
    Eligible patients will receive Orelabrutinib orally as per the protocol，until disease progression or other reasons for treatment discontinuation，whichever comes first.
  • Bendamustine Injection — DRUG
    Eligible patients will receive Bendamustine by injection as per the protocol
  • Rituximab — DRUG
    Eligible patients will receive Rituximab by injection as per the protocol
  • Orelabrutinib Placebo — DRUG
    Eligible patients will receive Orelabrutinib Placebo orally as per the protocol

Study Details

Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)

Key Dates

Start date
May 29, 2024
Status verified
Dec 2024
Primary completion
Jun 25, 2031
Completion
Jun 25, 2032

Study Design

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

Arms

  • Active Comparator: Arm A
  • Active Comparator: Arm B

Primary Outcome Measure

Dose-limiting toxicity (DLT) [ Time Frame: 28 days ]

Central Contacts

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