A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) Vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma
InnoCare Pharma Inc.
476 participants
May 29, 2024
INTERVENTIONAL
Conditions
Summary
Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)
Eligibility
Inclusion Criteria5
- Subjects ≥ 65 of age, or ≥ 60 and \< 65 years old who are ineligible for stem cell transplant or have refused stem cell transplantation due to reason(s) including: Have not received prior systemic therapies for MCL.
- Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator.
- Histopathological confirmed MCL, expression of Cyclin D1 and/or t (11; 14) chromosomal translocation. Either fresh tissue or FFPE for diagnosis must be sent to central lab for final confirmation after randomization.
- At least one measurable site of disease (the longest axis of the lymph node lesion is \> 1.5 cm, or the longest diameter of the extranodal lesion is \> 1.0 cm).
- ECOG PS score of 0 to 2.
Exclusion Criteria5
- Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.
- Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy.
- Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant.
- Use of strong inhibitors or strong inducers of cytochrome P450 3A within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment; or plan to use strong inhibitors or strong inducers of CYP3A during the study.
- Known central nervous system lymphoma.
Interventions
Eligible patients will receive Orelabrutinib orally as per the protocol，until disease progression or other reasons for treatment discontinuation，whichever comes first.
Eligible patients will receive Bendamustine by injection as per the protocol
Eligible patients will receive Rituximab by injection as per the protocol
Eligible patients will receive Orelabrutinib Placebo orally as per the protocol
Locations(39)
View Full Details on ClinicalTrials.gov
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NCT06363994