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NCT02341781 · ClinicalTrials.gov registry record
Observational Study of Lenalidomide in Subjects With Mantle Cell Lymphoma Who Failed Ibrutinib Treatment
A clinical trial of Lymphoma, Mantle-Cell, sponsored by Celgene.
- Completed
- Registry status
- 30
- Enrollment target
- 14
- Study locations
NCT02341781: Completed study of Lymphoma, Mantle-Cell, sponsored by Celgene.
NCT02341781 is a study of Lymphoma, Mantle-Cell that has completed, run by Celgene. The registered enrollment target is 30 participants, below the 232-participant average among 7 other Lymphoma, Mantle-Cell trials with a reported enrollment target (87% lower). The trial reports 14 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02341781, a study of Lymphoma, Mantle-Cell, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
- 14
- Study locations
Study 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.
Primary Outcome
Overall Response is defined as best response of Partial Remission (PR) or Complete Remission (CR) at any time during lenalidomide treatment.
Conditions Studied
Study Locations (14)
Arizona
- Mayo Clinic Scottsdale - Phoenix
California
- Innovative Clinical Research Institute - Whittier
Florida
- University of Miami and Sylvester Comprehensive Cancer - Miami
Michigan
- University of Michigan Comprehensive Cancer Center Division of Hematology Oncology - Ann Arbor
Missouri
- Columbia Comprehensive Cancer Care Clinic - Jefferson City
New Jersey
- Hackensack University Medical Center - Hackensack
New York
- Weill Cornell Medical College - New York
North Carolina
- Levine Cancer Institute - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-04 |
| Est. Completion | 2016-09 |
What the finished NCT02341781 record still lists
NCT02341781 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 232-participant average among 7 other Lymphoma, Mantle-Cell trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Lymphoma, Mantle-Cell appearing as the primary indexed condition, and to 0 interventions.
NCT02341781 lists 14 locations in 14 states (Arizona, California, Florida).
Frequently Asked Questions
What is clinical trial NCT02341781 about?
NCT02341781 is a clinical study titled "Observational Study of Lenalidomide in Subjects With Mantle Cell Lymphoma Who Failed Ibrutinib Treatment". 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 nee...
What is the current status of trial NCT02341781?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2015-04. Estimated completion is 2016-09.
What conditions does trial NCT02341781 study?
This clinical trial studies the following conditions: Lymphoma, Mantle-Cell.
Who is sponsoring clinical trial NCT02341781?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02341781 being conducted?
This trial has 14 study locations across Arizona, California, Florida, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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