Spots Global Cancer Trial Database for A Study of ABT-199 (Venetoclax) for Cutaneous T Cell Lymphoma (CTCL)

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: A Study of ABT-199 (Venetoclax) for Cutaneous T Cell Lymphoma (CTCL)

Official Title: A Single Arm, Open-Label Pilot Study of ABT-199 (Venetoclax) for Cutaneous T Cell Lymphoma (CTCL) Stage IB to IV

Study ID: NCT04171791

Conditions

CTCL

Interventions

ABT-199 (venetoclax)

Study Description

Brief Summary: The objective of this study are to evaluate the safety and tolerability of ABT-199 (venetoclax) in patients with advanced Cutaneous T cell lymphoma (CTCL). A secondary objective is to explore clinical response to ABT-199 (venetoclax) in patients with advanced CTCL.

Detailed Description: This is a single arm, open-label, non-randomized study with venetoclax (ABT-199) in CTCL patients (subtypes mycosis fungoides and Sézary syndrome only, and excluding transformed mycosis fungoides). This study is planned to be conducted in 18 patients, 18 years or older in age, undergoing a 5-week dose escalation protocol (per the US FDA package insert guidelines of venetoclax for CLL). Safety monitoring will continue throughout the whole period of drug administration and the treatment will be discontinued if intolerable toxicity (defined in Stopping Rules) or disease progression occurs during this period.