A Randomized, Controlled, Open-Label, Multicenter Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, Versus Temsirolimus in Subjects With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy
This is a randomized (individuals assigned to study treatment by chance), open-label
(identity of assigned study drug will be known), study to evaluate the efficacy and safety
of ibrutinib when compared with temsirolimus in patients with relapsed or refractory mantle
cell lymphoma (MCL) who have received at least 1 prior rituximab-containing chemotherapy
regimen. Approximately 280 eligible patients will be randomly assigned in a 1:1 ratio and
stratified (grouped) by the number of prior lines of therapy (1 or 2 versus >=3) and
simplified MCL International Prognostic Index criteria to receive either ibrutinib by mouth
(Treatment Arm A) or temsirolimus intravenous infusion (Treatment Arm B). The study will
consist of screening, treatment, and posttreatment phases. Data will be collected on disease
response to the treatment, progression-free survival, overall survival, subsequent anti-MCL
therapies, patient reported outcomes, and medical resource utilization. Tumor samples, blood
collected at multiple time points, and a bone marrow aspirate will be evaluated to identify
markers predictive of response or resistance to ibrutinib. 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. Disease evaluations will be performed every 9 weeks
for up to 15 months from the start of study drug, and every 24 weeks thereafter, until
disease progression, death, or the clinical cutoff, whichever comes first. Data will be
analyzed up to 3 years after the last patient is enrolled for the final follow-up.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
clinical cutoff (defined by 178 patients with progression free survival events; up to 3 years after the last patient is randomized)
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
United States: Food and Drug Administration
CR100848
NCT01646021
December 2012
March 2017
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