Elevate CLL TN: Study of Obinutuzumab + Chlorambucil, Acalabrutinib (ACP-196) + Obinutuzumab, and Acalabrutinib in Subjects With Previously Untreated CLL

Official Title

A Randomized, Multicentre, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, Acalabrutinib (ACP-196) in Combination With Obinutuzumab, and Acalabrutinib Monotherapy in Subjects With Previously Untreated CLL

Summary:

This study is evaluating the efficacy of obinutuzumab in combination with chlorambucil compared with ACP-196 in combination with obinutuzumab (Arm B) for the treatment of previously untreated chronic lymphocytic leukemia (CLL).

Trial Description

Primary Outcome Measures:

  • Progression-free survival in Arm A compared to Arm B
Secondary Outcome Measures:
  • IRC-assessed objective response rate (ORR) in Arm A versus Arm B and Arm A versus Arm C
  • Time to next treatment (TTNT) in Arm A versus Arm B and Arm A versus Arm C
  • Incidence of adverse events, serious adverse events and changes in laboratory measurements in Arm A versus Arm B and Arm A versus Arm C
  • Overall survival in Arm A versus Arm B and Arm A versus Arm C

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society