MCL-004: Observational Study of Lenalidomide in Subjects With Mantle Cell Lymphoma Who Failed Ibrutinib Treatment

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT02341781

Collaborator

(none)

Enrollment

Locations

17.1

Duration (Months)

2.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Mantle-Cell

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

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.

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Sep 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Overall Response Rate (ORR) [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.

Secondary Outcome Measures

Duration of response (DoR) [Approximately 5.7 years]
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.
Adverse Events [Approximately 5.7 years]
Number of participants with adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

no exclusion criteria.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Scottsdale	Phoenix	Arizona	United States	85054
2	Innovative Clinical Research Institute	Whittier	California	United States	90603
3	University of Miami and Sylvester Comprehensive Cancer	Miami	Florida	United States	33136
4	University of Michigan Comprehensive Cancer Center Division of Hematology Oncology	Ann Arbor	Michigan	United States	48109
5	Columbia Comprehensive Cancer Care Clinic	Jefferson City	Missouri	United States	65101
6	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
7	Weill Cornell Medical College	New York	New York	United States	10065
8	Levine Cancer Institute	Charlotte	North Carolina	United States	28204
9	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
10	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
11	Froedtert and The Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
12	Universitatsmedizin der Johannes Gutenberg- Universitat	Mainz	Rhineland-Palatinate	Germany	55131
13	Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi	Bologna	Emilia-Romagna	Italy	40138
14	Derriford Hospital Plymouth Oncology Center Clinical	Plymouth	Devon	United Kingdom	Pl68DH