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

Source: https://onco.cc/trials/nct06363994/  
OnCo record `nct06363994` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Orelabrutinib, Bendamustine, Rituximab in mantle cell lymphoma, run by InnoCare Pharma Inc., now recruiting.

## Summary

A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL is a phase 3 interventional study registered as NCT06363994 by InnoCare Pharma Inc., with 476 participants planned, started 2024-05-29 and due to reach its primary completion in 2031-06-25. Interventions recorded: Orelabrutinib, Bendamustine Injection, Rituximab, Orelabrutinib Placebo. Conditions listed: Mantle Cell Lymphoma. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: ctgov-ingest
- Registry id: NCT06363994
- Phase: 3
- Setting: 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
- Sponsor: InnoCare Pharma Inc.
- Enrolled: 476

## Sources

- ClinicalTrials.gov NCT06363994: https://clinicaltrials.gov/study/NCT06363994

## Connected records

- cancers: [Mantle cell lymphoma](https://onco.cc/cancers/mantle-cell-lymphoma/)
- drugs: [Bendamustine](https://onco.cc/drugs/bendamustine/), [Orelabrutinib](https://onco.cc/drugs/orelabrutinib/), [Rituximab](https://onco.cc/drugs/rituximab/)
- companies: [InnoCare Pharma](https://onco.cc/companies/innocare/)

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