Clinical trial NCT02943642: Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein in Subjects With Mycosis Fungoides
Official title: Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein (Resimmune®) in Subjects With Mycosis Fungoides: A Phase II Multi-center Randomized Clinical Trial
Conditions: Mycosis Fungoides
Summary: This study evaluates the effectiveness - as judged by complete response - of a single four-day treatment with the fusion protein A-dmDT390-bisFv(UCHT1) compared to oral Zolinza (Vorinostat), in a randomized 2-arm trial after a maximum of 12 months of treatment. Patient eligibility is stage IB/IIB mycosis fungoides with mSWAT < 50 who have never had lymphoid disease or a prior bone marrow / HSCT transplant.
Interventions:
description: anti-T cell immunotoxin (antibody targeting CD3 on T-cells tagged with diphtheria toxin without binding domain)
name: A-dmDT390-bisFv(UCHT1)
other_name: Resimmune® (proposed marketing designation)
type: Biological
description: ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies.
name: Vorinostat
other_name: Zolinza
type: Drug
Study arms:
design_group_description: A-dmDT390-bisFv(UCHT1) will be administered as Total Dose µg/kg given as 1/8 Total Dose µg/kg/injection twice a day 4-6 hours apart for four consecutive days (days 1-4) into a free flowing IV over a period of approximately 15 minutes.
design_group_title: A-dmDT390-bisFv(UCHT1)
design_group_type: Experimental
design_group_description: Subjects in the control arm will receive oral vorinostat capsules at a dose of 400 mg daily up to 12 months in duration until disease progression or uncontrolled side effects take place. Subjects in the vorinostat arm who experience progressive disease may cross over into the experimental arm after 6 months of treatment after a 2-week vorinostat washout period.
design_group_title: Vorinostat
design_group_type: Active Comparator
design_group_description: Dose Group 1: A-dmDT390-bisFv(UCHT1) will be administered as 5 µg/kg given as 0.625 µg/kg/injection twice a day 4-6 hours apart for four consecutive days (days 1-4) into a free flowing IV over a period of approximately 15 minutes.<br/>Dose Group 2: A-dmDT390-bisFv(UCHT1) will be administered as 10 µg/kg given as 1.25 µg/kg/injection twice a day 4-6 hours apart for four consecutive days (days 1-4) into a free flowing IV over a period of approximately 15 minutes.
design_group_title: Lead-in Dosing single arm
design_group_type: Experimental
Sponsor: Angimmune LLC
Collaborators: The University of Arkansas
The University of Texas Southwestern Medical Center
Ohio State University Comprehensive Cancer Center
Thomas Jefferson University
Rush University Medical Center
Columbia University
Yale University
Stanford University
City of Hope National Medical Center
Dana-Farber Cancer Institute, Inc.
Washington University School of Medicine
Vanderbilt University School of Medicine
University of Colorado Denver
H. Lee Moffitt Cancer Center & Research Institute, Inc.
Feinberg School of Medicine
University of Washington
Drug name mappings:
name: A-dmDT390-bisFv(National Institutes of Health)
lang: EN