A Study of Acalabrutinib in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Sponsor
Acerta Pharma BV
Study ID
NCT02735876
Phase
PHASE3
Status
Withdrawn

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is evaluating the efficacy of acalabrutinib in combination with rituximab (Arm 1) versus ibrutinib (Arm 2) versus acalabrutinib (Arm 3) for the treatment of relapsed or refractory (R/R) mantle cell lymphoma (MCL).

Key Dates

Start date
May 31, 2016
Status verified
Apr 2016
Primary completion
Jun 30, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: acalabrutinib plus rituximab
    Acalabrutinib will be orally administered until disease progression or unacceptable toxicity. Rituximab IV infusions will be administered weekly for 4 weeks and on Day 1 of Cycle 3 through 8, and thereafter every other cycle for less than or equal to two years (approximately 200 subjects).
  • Active Comparator: ibrutinib
    Ibrutinib will be orally administered until disease progression or unacceptable toxicity (approximately 200 subjects).
  • Experimental: acalabrutinib
    Acalabrutinib will be orally administered until disease progression or unacceptable toxicity (approximately 50 subjects).

Primary Outcome Measure

Progression-free survival (PFS) assessed by Independent Review Committee (IRC) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL). The primary analysis is a comparison of progression-free survival (PFS) between Arm 1 and Arm 2. [ Time Frame: 48 months ]

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