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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02460276
• Date of registration: 26/05/2015
• Prospective Registration: No
• Primary sponsor: Lund University Hospital
• Public title: A Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma PHILEMON
• Scientific title: A Phase II Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma
• Date of first enrolment: April 2015
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02460276
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Denmark, Finland, Norway, Sweden

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Relapsed/Refractory Mantle Cell Lymphoma

Intervention(s)

Drug: Rituximab

Drug: Lenalidomide

Drug: Ibrutinib

Primary Outcome(s)

Overall response rate. [Time Frame: Change of tumor burden meassured from baseline during treatment of maximum 144 weeks.]

Secondary ID(s)

NLG-MCL6

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Nordic Lymphoma Group

Celgene

Janssen, LP