A Study of Ibrutinib (a Bruton's Tyrosine Kinase Inhibitor), Versus Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy
- Conditions
- Relapsed or refractory Mantle Cell LymphomaMedDRA version: 14.1Level: LLTClassification code 10026808Term: Mantle zone lymphoma refractorySystem Organ Class: 100000004864MedDRA version: 14.1Level: LLTClassification code 10026807Term: Mantle zone lymphoma recurrentSystem Organ Class: 100000004864MedDRA version: 14.1Level: LLTClassification code 10026806Term: Mantle zone lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-000601-74-IT
- Lead Sponsor
- JANSSEN-CILAG INTERNATIONAL N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 280
1. 18 years of age or older. 2. Diagnosis of MCL reviewed and approved by central pathology laboratory prior to randomization - diagnosis report from local laboratory must include morphology and expression of either cyclin D1 in association with one B-cell marker (eg, CD19, CD20, or PAX5) and CD5 or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR) - if report from local laboratory is not available, diagnosis must be confirmed by central pathology laboratory based on the criteria above 3. 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. 4. Documented relapse or disease progression following the last anti-MCL treatment. 5. At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma. The site of disease must be greater than 1.5 cm in the long axis regardless of short axis measurement or greater than 1.0 cm in the short axis regardless of long axis measurement, and clearly measurable in 2 perpendicular dimensions. 6. Eastern Cooperative Oncology Group performance status grade 0 or 1 7. Hematology values must be within the following limits within 7 days prior to randomization: a. Absolute neutrophil count (ANC) = 1000/mm3 independent of growth factor support. b. Platelets = 75,000/mm3 or = 50,000/mm3 if bone marrow involvement independent of transfusion support. c. Hemoglobin level = 8 g/dL independent of transfusion support. 8. Biochemical values within the following limits within 7 days prior to randomization: a.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x upper limit of normal (ULN) b.Total bilirubin = 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin. c. Serum creatinine = 2 x ULN JNJ 54179060 d. Fasting serum cholesterol level = 350 mg/dL e. Fasting serum triglyceride level = 400 mg/dL 9. Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study (3 months for both men and women) consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during the study and for 3 months after receiving the last dose of study drug. 10.Women of childbearing potential must have a negative serum (ß-human chorionic gonadotropin [ß-hCG]) or urine pregnancy test at Screening. 11. Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
- Prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxinimmunoconjugates 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 - Requires treatment with strong CYP3A4/5 or CYP2D6 inhibitors - 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method