OncoMatch

OncoMatch/Clinical Trials/NCT06363994

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

Is NCT06363994 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Orelabrutinib and Bendamustine for mantle cell lymphoma.

Phase 3RecruitingInnoCare Pharma Inc.NCT06363994Data as of Jun 2026Location: China

Treatment: Orelabrutinib · Bendamustine · RituximabCompare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Rituximab

Targeted therapy

Orelabrutinib

Chemotherapy

Bendamustine

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Required: CCND1 overexpression

expression of Cyclin D1

Required: IGH t(11;14) chromosomal translocation

t (11; 14) chromosomal translocation

Disease stage

Required: Stage II, III, IV

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≥ 60

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06363994 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require CCND1?

Yes, CCND1 overexpression is a required biomarker for enrollment.

Does this trial require IGH?

Yes, IGH t(11;14) chromosomal translocation is a required biomarker for enrollment.

What disease stage is eligible?

Stage II or III or IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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