NCT02341781

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
4 countries

14 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

First Submitted

Initial submission to the registry

January 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

January 14, 2015

Last Update Submit

January 25, 2017

Conditions

Lymphoma, Mantle-Cell

Keywords

MANTLE CELL LYMPHOMAMulticenterObservationalLenalidomide (Revlimid®)Relapsed or progressedIbrutinib

Outcome Measures

Primary Outcomes (1)

  • 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.

    Approximately 5.7 years

Secondary Outcomes (2)

  • Duration of response (DoR)

    Approximately 5.7 years

  • Adverse Events

    Approximately 5.7 years

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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:
  • A. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Mayo Clinic Scottsdale

Phoenix, Arizona, 85054, United States

Location

Innovative Clinical Research Institute

Whittier, California, 90603, United States

Location

University of Miami and Sylvester Comprehensive Cancer

Miami, Florida, 33136, United States

Location

University of Michigan Comprehensive Cancer Center Division of Hematology Oncology

Ann Arbor, Michigan, 48109, United States

Location

Columbia Comprehensive Cancer Care Clinic

Jefferson City, Missouri, 65101, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Universitatsmedizin der Johannes Gutenberg- Universitat

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi

Bologna, Emilia-Romagna, 40138, Italy

Location

Derriford Hospital Plymouth Oncology Center Clinical

Plymouth, Devon, Pl68DH, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 29096668DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-CellRecurrence

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Oliver Manzke, MD

    Celgene Corporation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2015

First Posted

January 19, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

GB(1)IT(1)US(11)DE(1)