NCT02460276

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2015

Longer than P75 for phase_2

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

4.8 years

First QC Date

May 26, 2015

Last Update Submit

April 22, 2020

Conditions

Relapsed/Refractory Mantle Cell Lymphoma

Keywords

Mantle cell lymphomaRelapsed mantle cell lymphomaLenalidomideRituximabIbrutinibResponse durationComplete remission rateQuality of lifeOverall survivalSafety

Outcome Measures

Primary Outcomes (1)

  • Overall response rate.

    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.

Study Arms (1)

Lenalidomide, ibrutinib and rituximab.

EXPERIMENTAL
Drug: LenalidomideDrug: IbrutinibDrug: Rituximab

Interventions

LenalidomideDRUG
Lenalidomide, ibrutinib and rituximab.
IbrutinibDRUG
Lenalidomide, ibrutinib and rituximab.
RituximabDRUG
Lenalidomide, ibrutinib and rituximab.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +7 more criteria

You may not qualify if:

  • 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
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Rigshospitalet

Copenhagen, Denmark

Location

Helsinki University Hospital

Helsinki, Finland

Location

Norwegian Radium Hospital

Oslo, 0424, Norway

Location

Lund University Hospital

Lund, 221 85, Sweden

Location

Uppsala Akademiska Hospital

Uppsala, 751 85, Sweden

Location

Related Publications (1)

  • Jerkeman M, Eskelund CW, Hutchings M, Raty R, Wader KF, Laurell A, Toldbod H, Pedersen LB, Niemann CU, Dahl C, Kuitunen H, Geisler CH, Gronbaek K, Kolstad A. Ibrutinib, lenalidomide, and rituximab in relapsed or refractory mantle cell lymphoma (PHILEMON): a multicentre, open-label, single-arm, phase 2 trial. Lancet Haematol. 2018 Mar;5(3):e109-e116. doi: 10.1016/S2352-3026(18)30018-8. Epub 2018 Jan 29.

    PMID: 29396091DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

LenalidomideibrutinibRituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 2, 2015

Study Start

April 1, 2015

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

FI(1)NO(1)SE(2)DK(1)