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Spots Global Cancer Trial Database for A Dose-Ranging Study of IV BNZ-1 in LGL Leukemia or Refractory CTCL

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Trial Identification

Brief Title: A Dose-Ranging Study of IV BNZ-1 in LGL Leukemia or Refractory CTCL

Official Title: A Dose-Ranging Study of Intravenous BNZ132-1-40 in Patients With Large Granular Lymphocyte Leukemia or Refractory Cutaneous T-Cell Lymphoma

Study ID: NCT03239392

Interventions

BNZ132-1-40

Study Description

Brief Summary: This study is an open-label, multi-center, dose-ranging study to characterize the safety, tolerability, preliminary efficacy, and PK/PD of up to four dose levels of BNZ-1 administered weekly by IV infusion to adults diagnosed with Large Granular Lymphocyte (LGL) Leukemia or refractory Cutaneous T-cell Lymphoma (CTCL).

Detailed Description: This study is an open-label, multi-center, dose-ranging study to characterize the safety, tolerability, preliminary efficacy, and PK/PD of up to four dose levels of BNZ-1 administered weekly by IV infusion to adults diagnosed with LGL or CTCL. The study has 5 periods: * Screening Period * 4-week Treatment Period * 3-month Treatment Extension Period * Long-term Extension Period (open-ended) * 6-week Follow-up Period Subjects will be screened for eligibility within 30 days of study Day 1 (first dosing day of the 4-Week Treatment Period).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

City of Hope National Medical Center, Duarte, California, United States

Moffitt Cancer Center, Tampa, Florida, United States

The James Cancer Center, Ohio State University, Columbus, Ohio, United States

University of Virginia Cancer Center, Charlottesville, Virginia, United States

Contact Details

Name: Jonathan Brammer, MD, PhD

Affiliation: Ohio State University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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