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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

Phase 3
18 Years
Open (Enrolling)
Mantle Cell Lymphoma

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Trial Information

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.

Inclusion Criteria:

- Confirmed diagnosis of mantle cell lymphoma (MCL)

- Received at least 1 prior rituximab-containing chemotherapy regimen (separate lines
of therapy are defined as single or combination therapies that are either separated
by disease progression or by a > 6 month treatment-free interval)

- Documented relapse or disease progression following the last anti-MCL treatment

- At least 1 measurable site of disease according to Revised Response Criteria for
Malignant Lymphoma

- Eastern Cooperative Oncology Group performance status grade 0 or 1

- Protocol-defined hematology and biochemistry laboratory values

Exclusion Criteria:

- Prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic
anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10
weeks, radiation therapy or other investigational agents within 3 weeks, or major
surgery within 4 weeks of randomization

- Prior treatment with temsirolimus, other mTOR inhibitors, ibrutinib, or other
Bruton's tyrosine kinase (BTK) inhibitors

- Known central nervous system lymphoma

- Received an allogeneic or autologous hematopoietic stem cell transplant <=6 months
from the date of randomization and on immunosuppressive therapy or have evidence of
active graft versus host disease

- Diagnosed or treated for malignancy other than MCL, except: malignancy treated with
curative intent and with no known active disease present for >=3 years before
randomization, adequately treated non-melanoma skin cancer or lentigo maligna without
evidence of disease, adequately treated cervical carcinoma in situ without evidence
of disease

- History of stroke or intracranial hemorrhage within 6 months prior to randomization

- Requires anticoagulation with warfarin or equivalent vitamin K antagonist

- Requires treatment with strong CYP3A4/5 inhibitor

- Clinically significant cardiovascular disease such as uncontrolled or symptomatic
arrhythmias, congestive heart failure, or myocardial infarction within 6 months of
Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined
by the New York Heart Association Functional Classification

- Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV)
or active hepatitis B virus (HBV) infection or any uncontrolled active systemic
infection requiring intravenous antibiotics

- Woman who is pregnant or breast-feeding

- Any life-threatening illness, medical condition, or organ system dysfunction which,
in the investigator's opinion, could compromise the patient's safety, interfere with
the absorption or metabolism of ibrutinib capsules, or put the study outcomes at
undue risk

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

clinical cutoff (defined by 178 patients with progression free survival events; up to 3 years after the last patient is randomized)

Safety Issue:


Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC


United States: Food and Drug Administration

Study ID:




Start Date:

December 2012

Completion Date:

March 2017

Related Keywords:

  • Mantle Cell Lymphoma
  • Mantle cell lymphoma
  • Relapsed mantle cell lymphoma
  • Refractory mantle cell lymphoma
  • Ibrutinib
  • Bruton's tyrosine kinase inhibitor
  • Temsirolimus
  • Lymphoma
  • Lymphoma, Mantle-Cell