Mantle Cell Lymphoma Clinical Trial
Official title:
A Multi-center and Prospective Clinical Study of Orelabrutinib, Rituximab and Combination Chemotherapy in Patients With Newly-diagnosed Aggressive B-cell Non-Hodgkin Lymphoma
B-cell non-Hodgkin's lymphoma (B-NHL) is the most common type of NHL. Although novel immunotherapies represented by anti-CD20 monoclonal antibodies and CAR-T cell therapies have significantly improved the prognosis of B-NHL patients, there are still nearly one-third of patients who are resistant to initial treatment or relapse after remission. R-CHOP combined with novel drugs was expected to improve the prognosis. Therefore, this study aimed to investigate the potential of Orelabrutinib combined with Rituximab and chemotherapy.
Non-Hodgkin lymphoma (NHL), with high aggressiveness and mortality, is one of the top ten high-incidence tumors in the world and is among the ten most prevalent cancers worldwide with the fastest growing incidence. B-cell non-Hodgkin's lymphoma (B-NHL) is the most common type of NHL. Although novel immunotherapies represented by anti-CD20 monoclonal antibodies and CAR-T cell therapies have significantly improved the prognosis of B-NHL patients, there are still nearly one-third of patients who are resistant to initial treatment or relapse after remission. In recent years, the continuous emergence of various novel targeted agents has provided new hope for the treatment of B-NHL. Brutons tyrosine kinase (BTK) is a vital protein for immune B cell function, and a core switch of B cell growth, controlling cellular proliferation, differentiation, apoptosis and migration. BTK inhibitors were available as a breakthrough therapy at the end of 2013, providing a possibility of cure in patients with B-NHL. Orelabrutinib is a highly selective novel BTK inhibitor, and its latest clinical data was announced at the 62nd Annual Meeting of the American Society of Hematology (ASH) on Dec 7, 2020. In two clinical studies targeting relapsed/refractory mantle cell lymphoma (MCL) and relapsed/refractory chronic lymphocytic leukemia (CLL)/small cell leukemia (SLL), orelabrutinib showed a favorable overall remission rate (ORR) and safety. In a phase II clinical study on the treatment of relapsed/refractory CLL/SLL, at a median follow-up of 14.3 months, ORR was 91.3%. The median time to response was 1.87 months, and the median PFS or DOR was not reached. In a phase II clinical study on the treatment of relapsed/refractory MCL, at a median follow-up of 16.4 months, ORR was 87.9%. 93.9% of patients achieved disease control. However, the efficacy of orelabrutinib in highly aggressive B-cell lymphoma remains to be further studied. Therefore, we present this study protocol to add orelabrutinib to the first-line treatment of highly aggressive B-NHL, applying orelabrutinib+R-CHOP/R-EPOCH/R-HD-MTX/R-other regimens, to clarify the efficacy of orelabrutinib+R-CHOP/R-EPOCH/R-HD-MTX/R-other regimens and explore a set of potent and safe treatments for B-NHL patients with high risks and further improve the prognosis. ;
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