Trial Identifiers
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Scientific Title
An Australasian Leukaemia & Lymphoma Group (ALLG) Window study of Acalbrutinib plus Rituximab (Mabthera) followed by Cytarabine, Oxalipatin, Dexamethasone & Rituximab ( R-DHAOx) + Autologous Stem cell Transplant (ASCT) in fit Mantle Cell Lymphoma
Cooperative Group
Australasian Leukaemia and Lymphoma Group (ALLG)
Commercial Sponsor
Acerta Pharma BV
Summary
All eligible patients will receive Rituximab and Acalabrutinib, followed by 4 cycles of R-DHAOx chemotherapy at trial commencement. Patients who demonstrate at least a partial response to R-DHAOx, will go on to receive BEAM Autologous stem cell transplant in the consolidation phase of the trial, followed by maintenance therapy with Acalabrutinib and Rituximab. Patients who show less than partial response to R-DHAOx will be taken off study and treated as per the local treatment guidelines. The response will be determined by review of a PET/CT scan taken after the patient has completed 4 cycles of R-DHAOx.