Acalabrutinib With R-CHOP in Previously Untreated Mantle Cell Lymphoma

Titre officiel

A Phase II Study of Acalabrutinib in Combination With R-CHOP Chemotherapy in Previously Untreated Mantle Cell Lymphoma

Sommaire:

This is a multicentre, open-label, non-randomized, phase II clinical trial conducted in Canada. The purpose of the study is to determine the remission rate of acalabrutinib in combination with R-CHOP in patients with previously untreated mantle cell lymphoma prior to autologous stem cell transplantation. All patients will receive six cycles of R-CHOP chemotherapy together with continuous acalabrutinib at the standard dose twice per day orally. All patients will undergo response assessment at the end of six cycles of R-CHOP + acalabrutinib with CT scan, PET/CT scan, and bone marrow biopsy. Responding patients will proceed with stem cell mobilization, apheresis, and processing. Following ASCT, patients will receive standard maintenance rituximab every 3 months for 2 years.

Description de l'essai

Primary Outcome:

  • Complete response (CR) rate by PET/CT scan using Lugano Classification for Malignant Lymphoma
Secondary Outcome:
  • Adverse events of acalabrutinib and R-CHOP by using CTCAE version 5.0
  • Measures of efficacy by using the RECIL 2017 criteria.
  • Rate of minimal residual disease negativity (MRD) prior to transplant by flow cytometry
  • Event-free in patients who discontinue acalabrutinib at the point of MRD negativity prior to transplant by flow cytometry
  • Changes in scores of partient reported outcomes (PRO) as measured by FACT-Lym
  • Overall survival in patients who discontinue acalabrutinib at the point of MRD negativity
  • Changes in scores of partient reported outcomes (PRO) as measured by FACT-Cog
  • Changes in scores of partient reported outcomes (PRO) as measured by EORTC QLQ-C30

Voir cet essai sur ClinicalTrials.gov

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