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

Recruiting Phase 3 Interventional Study
Mantle Cell Lymphoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
60 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
476 (estimated)
Sponsor
InnoCare Pharma Inc. · Industry
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About This Trial

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

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Modified Ann Arbor stage II-IV. Patients with stage II re…
Contacts

Alexia Lu

010-66609745

CO_HGRAC@innocarepharma.com

CONTACT