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OncoMatch/Clinical Trials/NCT07377578

A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Is NCT07377578 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for mantle cell lymphoma.

Phase 3RecruitingGuangzhou Lupeng Pharmaceutical Company LTD.NCT07377578Data as of May 2026

Treatment: Rocbrutinib · Ibrutinib · Acalabrutinib · Zanubrutinib · OrelabrutinibMantle cell lymphoma (MCL) is an aggressive yet often indolent type of B-cell non-Hodgkin lymphoma (NHL). Rocbrutinib (LP-168) is a novel, highly selective, fourth-generation Bruton's tyrosine kinase (BTK) inhibitor that exhibits both covalent (irreversible) and non-covalent (reversible) binding. This unique dual mechanism of action has shown promising efficacy and a favorable safety profile across various B-cell NHL subtypes in prior Phase 1 and 2 studies. This is a Phase 3, randomized, open-label study comparing Rocbrutinib versus investigator's choice of BTK inhibitor (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) in patients with MCL who have received at least one prior line of therapy and are naïve to BTK inhibitor treatment (except for intolerance).

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Performance status

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

Prior therapy

Min 1 prior line

Cannot have received: btk inhibitor

Exception: intolerance

Lab requirements

Blood counts

adequate bone marrow hematopoietic function

Kidney function

adequate kidney function

Liver function

adequate liver function

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

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