Relapsed/Refractory Mantle Cell LymphomaPhase 2PHILEMONNCT02460276
A Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma
A Phase 2 study testing Lenalidomide, Ibrutinib and Rituximab in people with Relapsed/Refractory Mantle Cell Lymphoma, run by Lund University Hospital at 5 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Mantle Cell Lymphoma
- What is being tested?
- Lenalidomide, Ibrutinib and Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Apr 2015to 31 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Sweden2 sites
Lund University Hospital
Lund, 221 85
Uppsala Akademiska Hospital
Uppsala, 751 85
About this study
Official title: 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.
- Conditions
- Relapsed/Refractory Mantle Cell Lymphoma
- Being tested
- Lenalidomide, Ibrutinib, Rituximab
- Keywords
- Mantle cell lymphoma, Relapsed mantle cell lymphoma, Lenalidomide, Rituximab, Ibrutinib, Response duration, Complete remission rate, Quality of life, Overall survival, Safety
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
IbrutinibDrug
RituximabDrug
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide, ibrutinib and rituximab. | Experimental | Not described Receives: Drug: Lenalidomide; Drug: Ibrutinib; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate.
Tumor evaluation will be performed with CT/PET for maximum 144 weeks. Discontinuation of evaluation if the patient develops progressive disease.
Measured: Change of tumor burden meassured from baseline during treatment of maximum 144 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startApr 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed/Refractory Mantle Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene, Janssen, LP, Nordic Lymphoma Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460276
- Sponsor's protocol ID
- NLG-MCL6
- Acronym
- PHILEMON
- Status last verified
- Apr 2020
- First submitted
- 26 May 2015
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29396091
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT02460276
- Acronym / sponsor ID
- PHILEMON / NLG-MCL6
- Conditions
- Relapsed/Refractory Mantle Cell Lymphoma
- Keywords
- Mantle cell lymphoma, Relapsed mantle cell lymphoma, Lenalidomide, Rituximab, Ibrutinib, Response duration, Complete remission rate, Quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Collaborators
- Celgene, Janssen, LP, Nordic Lymphoma Group
- Study start
- Apr 2015
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide, ibrutinib and rituximab. | Experimental | Drug: Lenalidomide, Drug: Ibrutinib, Drug: Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenalidomide | Drug | Lenalidomide, ibrutinib and rituximab. |
| Ibrutinib | Drug | Lenalidomide, ibrutinib and rituximab. |
| Rituximab | Drug | Lenalidomide, ibrutinib and rituximab. |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 29396091Jerkeman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide, Ibrutinib and Rituximab in people with Relapsed/Refractory Mantle Cell Lymphoma, run by Lund University Hospital at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden, Denmark, Finland, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate. (time frame: Change of tumor burden meassured from baseline during treatment of maximum 144 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02460276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.