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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03587844
Other study ID # 18-147
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 3, 2018
Est. completion date July 2025

Study information

Verified date December 2023
Source Memorial Sloan Kettering Cancer Center
Contact Alison Moskowitz, MD
Phone 646-608-3726
Email moskowia@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test any good and bad effects of the study drug called brentuximab vedotin at a lower dose than is FDA-approved.


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Study Design


Intervention

Drug:
brentuximab vedotin
MF/SS Brentuximab vedotin 0.9 mg/kg 0R 1.2 mg/kg.
brentuximab vedotin
LyP Brentuximab vedotin 0.9 mg/kg2
brentuximab vedotin
MF/SS prior brentuximab vedotin-Brentuximab vedotin dose to be determined from Cohort 1

Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack Commack New York
United States Memorial Sloan Kettering Westchester Harrison New York
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Stanford University Medical Center Stanford California
United States Memorial Sloan Kettering Nassau Uniondale New York

Sponsors (2)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Seagen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall response measure best overall response during treatment by the global response score, which incorporates the mSWAT, as well as CT scan for patients with baseline nodal/visceral involvement and flow cytometry for patients with baseline positive peripheral flow cytometry 1 year
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