Clinical Trial: A Study to Evaluate the Efficacy and Safety of Ibrutinib, in Patients With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2, Multicenter, Single-Arm, Study to Evaluate the Efficacy and Safety of Single-Agent Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Mantle Cell Ly

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of ibrutinib in patients with mantle cell lymphoma who received at least 1 prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy.

Detailed Summary: This is a single-arm (all patients will receive the study drug) study to evaluate the efficacy and safety of ibrutinib in patients with mantle cell lymphoma (MCL) who have received at least 1 rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy. Approximately 110 eligible patients will be enrolled. During the treatment phase, patients will receive 560 mg of ibrutinib by mouth once daily continuously until disease progression, unacceptable toxicity, or study end, whichever occurs first. Treatment will be continuous (without interruption) and self-administered at home. Doses can be held or reduced based on the severity of and the recovery from side effects of the study drug. The sponsor will ensure that patients benefiting from treatment with ibrutinib will be able to continue treatment after the end of the study. Data will be collected on disease response to the treatment, on progression-free survival, overall survival, and subsequent anti-MCL therapies. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected as detailed in the protocol. Safety will be monitored throughout the study. An interim analysis of the pharmacokinetic data will occur approximately 3 months after the scheduled pharmacokinetic sampling in Cycles 1 and 2 has been completed. Data will be analyzed 1 year after the last patient is enrolled for the primary analysis and 2 years after last patient is enrolled for the final follow-up.
Sponsor: Janssen Research & Development, LLC

Current Primary Outcome: Overall response rate [ Time Frame: 1 year after the last patient is enrolled ]

Original Primary Outcome: Overall response rate [ Time Frame: 6 months after the last patient is enrolled ]

Current Secondary Outcome:

  • Overall survival rate [ Time Frame: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled ]
  • Progression-free survival rate [ Time Frame: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled ]
  • Mean change from baseline in the Lym subscale [ Time Frame: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled ]
  • Mean change from baseline in the EQ-5D-5L index [ Time Frame: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled ]
  • Mean plasma concentrations of ibrutinib [ Time Frame: Up to Cycle 2, Day 21 ]
  • Maximum observed plasma concentration of ibrutinib [ Time Frame: Up to Cycle 2, Day 21 ]
  • Minimum observed plasma concentration of ibrutinib [ Time Frame: Up to Cycle 2, Day 21 ]
  • Area under the plasma concentration-time curve from time 0 to 24 hours of ibrutinib [ Time Frame: Up to Cycle 2, Day 21 ]
  • The number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of study medication ]
  • Overall response rate [ Time Frame: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled ]


Original Secondary Outcome:

  • Overall survival rate [ Time Frame: 6 months after the last patient is enrolled and 2 years after the last patient is enrolled ]
  • Progression-free survival rate [ Time Frame: 6 months after the last patient is enrolled and 2 years after the last patient is enrolled ]
  • Mean change from baseline in the Lym subscale [ Time Frame: 6 months after the last patient is enrolled and 2 years after the last patient is enrolled ]
  • Mean change from baseline in the EQ-5D-5L index [ Time Frame: 6 months after the last patient is enrolled and 2 years after the last patient is enrolled ]
  • Mean plasma concentrations of ibrutinib [ Time Frame: Up to Cycle 2, Day 21 ]
  • Maximum observed plasma concentration of ibrutinib [ Time Frame: Up to Cycle 2, Day 21 ]
  • Minimum observed plasma concentration of ibrutinib [ Time Frame: Up to Cycle 2, Day 21 ]
  • Area under the plasma concentration-time curve from time 0 to 24 hours of ibrutinib [ Time Frame: Up to Cycle 2, Day 21 ]
  • The number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of study medication ]
  • Overall response rate [ Time Frame: 6 months after the last patient is enrolled and 2 years after the last patient is enrolled ]


Information By: Janssen Research & Development, LLC

Dates:
Date Received: May 14, 2012
Date Started: August 2012
Date Completion:
Last Updated: May 27, 2016
Last Verified: May 2016