Status:
TERMINATED
PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Mycosis Fungoides Who Have Completed the SOLAR Study
Lead Sponsor:
miRagen Therapeutics, Inc.
Conditions:
Cutaneous T-Cell Lymphoma/Mycosis Fungoides
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtyp...
Detailed Description
Study Design: Up to 60 subjects are expected to be enrolled after discontinuation from the SOLAR clinical study (MRG106-11-201). Cobomarsen will be administered in the clinic by 2-hr intravenous infu...
Eligibility Criteria
Inclusion
- Key
- Must have participated in the comparator arm of the SOLAR clinical trial and completed the study (confirmed disease progression).
- Key
Exclusion
- Sézary syndrome or mycosis fungoides with B2 involvement, defined as documented history of B2 and/or B2 staging at screening.
- Evidence of large cell transformation.
- Visceral involvement related to MF at screening.
- Unresolved toxicities from prior vorinostat treatment, defined as having not resolved to CTCAE v5.0 grade 0 or 1.
- Any CTCL systemic therapy after completion of the SOLAR study and prior to Day 1 for PRISM.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03837457
Start Date
October 1 2019
End Date
July 27 2020
Last Update
November 19 2020
Active Locations (9)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
3
Washington University School of Medicine
St Louis, Missouri, United States, 63108
4
The Ohio State University and Wexner Medical Center
Columbus, Ohio, United States, 43210