Study of IbrutNCT03112174inib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO)

Official Title

Phase 3 Study of Ibrutinib in Combination With Venetoclax in Subjects With Mantle Cell Lymphoma

Summary:

This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.

Trial Description

Primary Outcome:

  • Occurrence of Tumour Lysis Syndrome (TLS) (Safety Run-in Period)
  • Occurrence of Dose Limiting Toxicities (DLT) (Safety Run-in Period)
  • Percentage of participants experiencing Adverse Events (Safety Run-in Period)
  • Overall response rate (ORR) (Safety Run-in Period)
  • Duration of Response (DOR) (Safety Run-in Period)
  • Progression-free Survival (PFS) (Safety Run-in Period)
  • Overall Survival (OS) (Safety Run-in Period)
  • Progression-free Survival (PFS) (Randomization Period)
  • Complete Response (CR) (Treatment-Naive Arm)
Secondary Outcome:
  • Complete Response (CR) (Randomization Period)
  • Overall response rate (ORR) (Randomization Period and Treatment-Naive Arm)
  • MRD-negative remission rate in participants who achieve CR per investigator assessment (Randomization Period and Treatment-Naive Arm)
  • Overall Survival (OS) (Randomization Period and Treatment-Naive Arm)
  • Duration of Response (DOR) (Randomization Period and Treatment-Naive Arm)
  • Time to Next Treatment (TTNT) (Randomization Period and Treatment-Naive Arm)
  • Percentage of participants experiencing Adverse Events (Randomization Period)
  • Occurrence of Tumour Lysis Syndrome (TLS) (Randomization Period)
  • Cmax if Ibrutinib (Randomization Period)
  • Tmax if Ibrutinib (Randomization Period)
  • AUClast if Ibrutinib (Randomization Period)
  • Half-Life (T1/2) if Ibrutinib (Randomization Period)
  • Cmax of Venetoclax (Randomization Period)
  • Tmax of Venetoclax (Randomization Period)
  • AUC of Venetoclax (Randomization Period)
  • Time to worsening in FACT-Lym subscale of the health-related quality of life (Randomization Period) questionnaire (FACT-Lym)
  • Duration of CR (Treatment-Naive Arm Period)
  • Progression-free Survival (PFS) (Treatment-Naive Arm Period)

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