Lymphoma, Mantle-CellMCL-004NCT02341781
Observational Study of Lenalidomide in Subjects With Mantle Cell Lymphoma Who Failed Ibrutinib Treatment
An observational study of Lymphoma, Mantle-Cell, run by Celgene at 14 sites in 4 countries.
Trial summary
The objective of this study is to determine the effectiveness of lenalidomide in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL) following ibrutinib treatment. MCL subjects who require treatment after receiving ibrutinib therapy are considered a population with high unmet medical need. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Mantle-Cell
- How many people
- 30 participants
- Where
- 14 sitesin 4 countries
- Study dates
- Apr 2015to Sep 2016
- Phase
- Observational
- 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
Study population: Mantle Cell Lymphoma (MCL) subjects who received lenalidomide, either as monotherapy or as combination treatment, after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment. Lenalidomide does not need to be the next subsequent treatment after ibrutinib.
Who may be able to join
- Understand and voluntarily sign an informed consent document (ICD), if applicable, prior to any collection of study-related data.
- Males or females ≥ 18 years of age at the time of signing the ICD (if informed consent is applicable)
- Diagnosis of Mantle Cell Lymphoma (MCL) as assessed by the investigator. A copy of a pathology report establishing the diagnosis of MCL must be available
- Must have received at least one dose of ibrutinib and must have met at least one of the following criteria:
- Relapse: Subjects with relapse following initial response of CR to ibrutinib (or an ibrutinib-containing regimen). Subjects may have discontinued or completed ibrutinib treatment at the time of relapse, and there is no upper limit on the time between the last dose of ibrutinib to time of relapse. B. Progressive disease (PD): Subjects with PD following initial response of PR to ibrutinib (or an ibrutinib-containing regimen). Subjects may have discontinued or completed ibrutinib at the time of progression, and there is no upper limit on the time between the last dose of ibrutinib to time of progression. C. Refractoriness: Subjects with i. Best response of stable disease (SD) during treatment with ibrutinib (or an ibrutinib-containing regimen), and then subsequently had PD, or ii. Best response of PD at anytime while on ibrutinib (or an ibrutinib-containing regimen) D. Intolerance: Subjects requiring premature discontinuation of ibrutinib for reasons other than PD prior to the planned end of treatment. Potential reasons for premature discontinuation may include Adverse Event (AE) attributed to ibrutinib or inability to continue ibrutinib for other reasons. Subjects responding to ibrutinib treatment must have documented PD/relapse following discontinuation of ibrutinib. The reason for the premature discontinuation of ibrutinib will be recorded.
Who cannot join
- no exclusion criteria.
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
United States11 sites
University of Michigan Comprehensive Cancer Center Division of Hematology Oncology
Ann Arbor, Michigan, 48109
Levine Cancer Institute
Charlotte, North Carolina, 28204
Hackensack University Medical Center
Hackensack, New Jersey, 07601
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Columbia Comprehensive Cancer Care Clinic
Jefferson City, Missouri, 65101
University of Miami and Sylvester Comprehensive Cancer
Miami, Florida, 33136
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Weill Cornell Medical College
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic Scottsdale
Phoenix, Arizona, 85054
Innovative Clinical Research Institute
Whittier, California, 90603
Germany1 site
Universitatsmedizin der Johannes Gutenberg- Universitat
Mainz, Rhineland-Palatinate, 55131
Italy1 site
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi
Bologna, Emilia-Romagna, 40138
United Kingdom1 site
Derriford Hospital Plymouth Oncology Center Clinical
Plymouth, Devon, Pl68DH
About this study
Official title: A Multicenter, Observational Study to Evaluate the Effectiveness of Lenalidomide (Revlimid®) in Subjects With Mantle Cell Lymphoma Who Have Relapsed or Progressed After Treatment With Ibrutinib or Are Refractory or Intolerant to Ibrutinib.
The objective of this study is to determine the effectiveness of lenalidomide in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL) following ibrutinib treatment. MCL subjects who require treatment after receiving ibrutinib therapy are considered a population with high unmet medical need. It is therefore of benefit to have data on the outcomes of treatment options available in this patient population.
An observational study design was chosen to collect the clinical data already existing or being collected for MCL subjects being treated with lenalidomide.
MCL subjects who received lenalidomide either as monotherapy or as combination treatment after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment are eligible for the study. Lenalidomide does not need to be the next subsequent treatment after ibrutinib.
- Conditions
- Lymphoma, Mantle-Cell
- Keywords
- MANTLE CELL LYMPHOMA, Multicenter, Observational, Lenalidomide (Revlimid®), Relapsed or progressed, Ibrutinib
- Medical subject headings
- Lymphoma, Mantle-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Relapsed,Progressed,Refractory or Intolerant to ibrutinib | MCL subjects who received lenalidomide after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Overall Response is defined as best response of Partial Remission (PR) or Complete Remission (CR) at any time during lenalidomide treatment.
Measured: Approximately 5.7 years
Secondary outcomes (2)
Duration of response (DoR)
DoR is defined as the time from the date of the initial response of at least PR (PR or CR) to the date of progressive disease (PD) or relapse.
Measured: Approximately 5.7 years
Adverse Events
Number of participants with adverse events.
Measured: Approximately 5.7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2016
- Study completionSep 2016
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 Lymphoma, Mantle-CellStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oliver Manzke, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341781
- Sponsor's protocol ID
- CC-5013-MCL-004
- Acronym
- MCL-004
- Status last verified
- Jan 2017
- First submitted
- 14 Jan 2015
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang M, Schuster SJ, Phillips T, Lossos IS, Goy A, Rule S, Hamadani M, Ghosh N, Reeder CB, Barnett E, Bravo MC, Martin P. Observational study of lenalidomide in patients with mantle cell lymphoma who relapsed/progressed after or were refractory/intolerant to ibrutinib (MCL-004). J Hematol Oncol. 2017 Nov 2;10(1):171. doi: 10.1186/s13045-017-0537-5.
PubMed 29096668
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Observational Study to Evaluate the Effectiveness of Lenalidomide (Revlimid®) in Subjects With Mantle Cell Lymphoma Who Have Relapsed or Progressed After Treatment With Ibrutinib or Are Refractory or Intolerant to Ibrutinib.
- ClinicalTrials.gov ID
- NCT02341781
- Acronym / sponsor ID
- MCL-004 / CC-5013-MCL-004
- Conditions
- Lymphoma, Mantle-Cell
- Keywords
- MANTLE CELL LYMPHOMA, Multicenter, Observational, Lenalidomide (Revlimid®), Relapsed or progressed, Ibrutinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Jan 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.
The objective of this study is to determine the effectiveness of lenalidomide in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL) following ibrutinib treatment. MCL subjects who require treatment after receiving ibrutinib therapy are considered a population with high unmet medical need. It is therefore of benefit to have data on the outcomes of treatment options available in this patient population.
An observational study design was chosen to collect the clinical data already existing or being collected for MCL subjects being treated with lenalidomide.
MCL subjects who received lenalidomide either as monotherapy or as combination treatment after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment are eligible for the study. Lenalidomide does not need to be the next subsequent treatment after ibrutinib.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relapsed,Progressed,Refractory or Intolerant to ibrutinib | – | –MCL subjects who received lenalidomide after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mantle Cell Lymphoma (MCL) subjects who received lenalidomide, either as monotherapy or as combination treatment, after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment. Lenalidomide does not need to be the next subsequent treatment after ibrutinib.
Key inclusion criteria (5 listed)
- Understand and voluntarily sign an informed consent document (ICD), if applicable, prior to any collection of study-related data.
- Males or females ≥ 18 years of age at the time of signing the ICD (if informed consent is applicable)
- Diagnosis of Mantle Cell Lymphoma (MCL) as assessed by the investigator. A copy of a pathology report establishing the diagnosis of MCL must be available
- Must have received at least one dose of ibrutinib and must have met at least one of the following criteria:
- Relapse: Subjects with relapse following initial response of CR to ibrutinib (or an ibrutinib-containing regimen). Subjects may have discontinued or completed ibrutinib treatment at the time of relapse, and there is no upper limit on the time between the last dose of ibrutinib to time of relapse. B. Progressive disease (PD): Subjects with PD following initial response of PR to ibrutinib (or an ibrutinib-containing regimen). Subjects may have discontinued or completed ibrutinib at the time of progression, and there is no upper limit on the time between the last dose of ibrutinib to time of progression. C. Refractoriness: Subjects with i. Best response of stable disease (SD) during treatment with ibrutinib (or an ibrutinib-containing regimen), and then subsequently had PD, or ii. Best response of PD at anytime while on ibrutinib (or an ibrutinib-containing regimen) D. Intolerance: Subjects requiring premature discontinuation of ibrutinib for reasons other than PD prior to the planned end of treatment. Potential reasons for premature discontinuation may include Adverse Event (AE) attributed to ibrutinib or inability to continue ibrutinib for other reasons. Subjects responding to ibrutinib treatment must have documented PD/relapse following discontinuation of ibrutinib. The reason for the premature discontinuation of ibrutinib will be recorded.
Key exclusion criteria (1 listed)
- no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Response Rate (ORR)
Time frame: Approximately 5.7 years
Overall Response is defined as best response of Partial Remission (PR) or Complete Remission (CR) at any time during lenalidomide treatment.
2 secondary outcomes
Duration of response (DoR)
Time frame: Approximately 5.7 years
Adverse Events
Time frame: Approximately 5.7 years
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 26 Jan 2017.
- Derived from this study: PubMed 29096668Wang M, Schuster SJ, Phillips T, Lossos IS, Goy A, Rule S, Hamadani M, Ghosh N, Reeder CB, Barnett E, Bravo MC, Martin P. Observational study of lenalidomide in patients with mantle cell lymphoma who relapsed/progressed after or were refractory/intolerant to ibrutinib (MCL-004). J Hematol Oncol. 2017 Nov 2;10(1):171. doi: 10.1186/s13045-017-0537-5.
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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.
Oliver Manzke, MD study director
Celgene Corporation
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Mantle-Cell, run by Celgene at 14 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 5 inclusion and 1 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 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Germany, Italy, United Kingdom. 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.
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 (ORR) (time frame: Approximately 5.7 years). 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 NCT02341781, 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 26 Jan 2017.