- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02460276
A Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma (PHILEMON)
A Phase II Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma
In this trial, patients with mantle cell lymphoma will be included, treatment with lenalidomide, rituximab and ibrutinib will be administered in an induction phase for up to 12 cycles, cycle length 28 days. Patients with complete remission, partial response or stable disease will enter a maintenance phase with treatment with ibrutinib and rituximab until progression of disease.
The primary objective is to evaluate overall response rate, based on PET and CT.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age over 18 years
- Histologically confirmed (according to the WHO 2008, and upcoming 2015 classification) mantle cell lymphoma stage II-IV
- Received at least 1 prior rituximab-containing chemotherapy regimen
- Documented relapse or disease progression following the last anti-mantle cell lymphoma treatment
- At least 1 measurable site of disease (over 1.5 cm long axis)
- WHO performance status 0-3
- Written informed concent
Female subjects of childbearing potential must:
- Understand that the study medication is expected to have a teratogenic effect
- Agree to use, and be able to comply with, highly effective contraception without interruption, 4 weeks Before start study drug, throughout study drug therapy (including dose interruptions) and for 12 months after the end of study drug therapy, even if she has amenorrhoea
- Women of childbearing potential must have a negative serum (beta-human ionic gonadotropin or urine pregnancy test at screening. Women who are pregnant or breastfeeding are ineligible for this study
Male subjects must:
- Agree to use condoms throughout study drug therapy, during any dose interruption and for 3 months after cessation of study therapy if their partner is of childbearing potential and has no contraception
- Agree not to donate semen during study drug therapy and for 3 months after end of study drug therapy
- All subjects must agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy
- All subjects must agree not to share study medication with another person and to return all unused study drug to the investigator
- Absolute neutrophil Count (ANC) ≥ 1000/mm3
- Platelets ≥ 100,000/mm3 or ≥50,000/mm3 if bone marrow involvement independent of transfusion support in either situation
- Alanine aminotransferase (ALT) and aspartate aminotransferase ≤ 3 x upper limit of normal (ULN).
- Total bilirubin ≤ 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
- Serum creatinine ≤ 2 x ULN or estimated Glomerular Filtration Rate (Cockcroft-Gault) ≥ 40 mL/min/1.73 m2
- 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, including biomarkers, and are willing to participate in the study
Exclusion Criteria:
- Chemotherapy or radiotherapy within 3 weeks, therapeutic antibodies within 4 weeks, radioimmunotherapy within 10 weeks, or major surgery within 4 weeks of inclusion
- Known central nervous system lymphoma
- Other active malignancy
- Psychiatric illness or condition which could interfere with the subjects' ability to understand the requirements of the study
- Requirement of corticosteroid therapy at a dose > 10 mg prednisolone/day
- Major surgery within 4 weeks of inclusion
- History of stroke or intracranial hemorrhage within 6 months prior to inclusion
- Requirement of anticoagulation treatment with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon)
- Requirement of treatment with strong or moderate CYP3A inhibitors
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrythmias, 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
- Vaccination with live, attenuated vaccines within 4 weeks of inclusion
- Known history of human immunodeficiency virus (HIV) or Active hepatitis C Virus or Active Hepatitis B Virus infection or any uncontrolled Active systemic infection requiring intravenous antibiotics
- 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 lenalidomide tablets, or put the study outcomes at undue risk
- Known hypersensitivity or allergy to rituximab, lenalidomide or ibrutinib
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lenalidomide, ibrutinib and rituximab.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate.
Time Frame: Change of tumor burden meassured from baseline during treatment of maximum 144 weeks.
|
Tumor evaluation will be performed with CT/PET for maximum 144 weeks.
Discontinuation of evaluation if the patient develops progressive disease.
|
Change of tumor burden meassured from baseline during treatment of maximum 144 weeks.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Mantle-Cell
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
- Rituximab
Other Study ID Numbers
- NLG-MCL6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Relapsed/Refractory Mantle Cell Lymphoma
-
Prelude TherapeuticsCompletedAdenoid Cystic Carcinoma | Refractory Chronic Myelomonocytic Leukemia | Relapsed/Refractory Acute Myeloid Leukemia | Relapsed/Refractory Mantle Cell Lymphoma | Relapsed/Refractory Diffuse Large B-cell Lymphoma | Relapsed/Refractory Advanced Solid Tumors | Relapsed/Refractory Myelodysplasia | Relapsed...United States
-
BeiGeneRecruitingMantle Cell Lymphoma | Relapsed Mantle Cell Lymphoma | Refractory Mantle Cell Lymphoma (MCL)United States, China, Israel, Belgium, Poland, Spain, Turkey, Brazil, Italy, Canada, United Kingdom, France, Germany, Argentina
-
BeiGeneCompletedRefractory Mantle Cell Lymphoma | Relapsed Mantle Cell LymphomaChina
-
Kite, A Gilead CompanyRecruitingRelapsed/Refractory Mantle Cell Lymphoma | Relapsed/Refractory B-precursor Acute Lymphoblastic LeukemiaJapan
-
Fondazione Italiana Linfomi - ETSRecruitingRefractory Mantle Cell Lymphoma | Relapsed Mantle Cell LymphomaItaly
-
AstraZenecaActive, not recruitingPhase I: Relapsed or Refractory B-cell Malignancies | Phase II Cohort A: Relapsed or Refractory Mantle Cell Lymphoma | Phase II Cohort B: Relapsed or Refractory Chronic Lymphocytic LeukemiaChina
-
Kite, A Gilead CompanyCompletedRelapsed/Refractory Mantle Cell LymphomaUnited States, Netherlands, Germany, France
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownRelapsed / Refractory Mantle Cell Lymphoma (MCL)China
-
Kite, A Gilead CompanyActive, not recruitingRelapsed/Refractory Mantle Cell LymphomaUnited States, France, Spain, United Kingdom, Netherlands, Germany
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI); Gilead Sciences; Celgene Corporation; Biologics...CompletedRelapsed/Refractory Mantle Cell LymphomaUnited States
Clinical Trials on Rituximab
-
Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingEBV-Related Post-Transplant Lymphoproliferative Disorder | Monomorphic Post-Transplant Lymphoproliferative Disorder | Polymorphic Post-Transplant Lymphoproliferative Disorder | Recurrent Monomorphic Post-Transplant Lymphoproliferative Disorder | Recurrent Polymorphic Post-Transplant Lymphoproliferative... and other conditionsUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingRecurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Mantle Cell Lymphoma | Recurrent Marginal Zone Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Recurrent Small Lymphocytic Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent Grade 3a Follicular... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingAnn Arbor Stage I Grade 1 Follicular Lymphoma | Ann Arbor Stage I Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 1 Follicular Lymphoma | Ann Arbor Stage II Grade 2 Follicular LymphomaUnited States
-
National Cancer Institute (NCI)CompletedAnn Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma | Ann Arbor Stage II Grade 3 Non-Contiguous... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Small Lymphocytic Lymphoma | Prolymphocytic Leukemia | Recurrent Chronic Lymphocytic LeukemiaUnited States
-
PfizerCompletedRheumatoid ArthritisUnited States, Australia, Canada, Israel, Mexico, Colombia, Germany, Russian Federation, South Africa, United Kingdom
-
National Cancer Institute (NCI)Celgene CorporationActive, not recruitingAnn Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma | Ann Arbor Stage II Grade 3 Non-Contiguous... and other conditionsUnited States
-
Mabion SAParexelWithdrawn
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Mantle Cell Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Refractory Mantle Cell LymphomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingStage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States, Canada