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A Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma (PHILEMON)

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ClinicalTrials.gov Identifier: NCT02460276
Recruitment Status : Recruiting
First Posted : June 2, 2015
Last Update Posted : June 28, 2017
Sponsor:
Collaborators:
Celgene
Janssen, LP
Nordic Lymphoma Group
Information provided by (Responsible Party):
Lund University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Relapsed/Refractory Mantle Cell Lymphoma Drug: Lenalidomide Drug: Ibrutinib Drug: Rituximab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma
Study Start Date : April 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Lenalidomide, ibrutinib and rituximab. Drug: Lenalidomide
Drug: Ibrutinib
Drug: Rituximab



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Understand that the study medication is expected to have a teratogenic effect
    2. 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
    3. 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:

    1. 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
    2. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460276


Contacts
Contact: Mats Jerkeman, MD, PhD +46 46 17 75 20 mats.jerkeman@med.lu.se

Locations
Denmark
Rigshospitalet Not yet recruiting
Copenhagen, Denmark
Contact: Martin Hutchings, MD, PhD       martin.hutchings@regionh.dk   
Principal Investigator: Martin Hutchings, MD, PhD         
Finland
Helsinki University Hospital Not yet recruiting
Helsinki, Finland
Contact: Riikka Räty, MD, PhD    +358 10 328 1900    riikka.raty@hus.fi   
Principal Investigator: Riikka Räty, MD, PhD         
Norway
Norwegian Radium Hospital Not yet recruiting
Oslo, Norway, 0424
Contact: Arne Kolstad, MD, PhD    +47 915 02 770    arne.kolstad@oslo-universitetssykehus.no   
Principal Investigator: Arne Kolstad, MD, PhD         
Sweden
Lund University Hospital Recruiting
Lund, Sweden, 221 85
Contact: Mats Jerkeman, MD, PhD    +46 46 17 75 20    mats.jerkeman@med.lu.se   
Principal Investigator: Mats Jerkeman, MD, PhD         
Uppsala Akademiska Hospital Recruiting
Uppsala, Sweden, 751 85
Contact: Anna Laurell, MD, PhD    018-611 00 00    anna.laurell@akademiska.se   
Principal Investigator: Anna Laurell, MD, PhD         
Sponsors and Collaborators
Lund University Hospital
Celgene
Janssen, LP
Nordic Lymphoma Group

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT02460276     History of Changes
Other Study ID Numbers: NLG-MCL6
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: September 2016

Keywords provided by Lund University Hospital:
Mantle cell lymphoma
Relapsed mantle cell lymphoma
Lenalidomide
Rituximab
Ibrutinib
Response duration
Complete remission rate
Quality of life
Overall survival
Safety

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lenalidomide
Rituximab
Thalidomide
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents