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

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
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
394 (estimated)
Sponsor
Guangzhou Lupeng Pharmaceutical Company LTD. · Industry
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About This Trial
Mantle 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 acros…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Diagnosed with MCL, who have received at least one prior systemic regimen(s), and have experienced disease progression on the most recent line of therapy. * Have at least one measurable lesion according to the Lugano Response Criteria 2014. * Eastern Cooperative Oncology Group…
Contacts

Yuqin Song

+86-010-88196118

SongYQ_VIP@163.com

CONTACT