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

Completed

• Conditions: an aggressive cancer of a kind of white blood cells; Non-Hodgkin lymphoma; who are called B-lymfocytes; 10025320

• Registration Number: NL-OMON40109
• Lead Sponsor: Janssen Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

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 biochemical laboratory values;Major Inclusion Criteria for Cross Over to Ibrutinib treatment:
- IRC-confirmed disease progression after treatment with temsirolimus, and medical monitor
approval.
- Protocol-defined hematology and biochemical 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;-Criterion modified per amendment: Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon).
- Criterion modified per amendment: Requires treatment with a 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 subject*s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk;Major Exclusion Criteria for Cross Over to Ibrutinib treatment:
- prior history of stroke or intracranial hemorrhage within 6 months prior to
crossover treatment.
- require anticoagulation with warfarin or equivalent vitamin K antagonists
(eg, phenprocoumon).
- require treatment with a strong CYP3A inhibitor
- clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of pre-crossover screening.
- life-threatening illness, medical condition, or organ system dysfunction which, in the investigator*s opinion, could compromise the subject*s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
- women who are pregnant or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified