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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT04171791
Phase
PHASE1
Status
Completed

Conditions

  • CTCL

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABT-199 (venetoclax) — DRUG
    Eligible patients will be enrolled into the study and receive venetoclax daily per the US FDA package insert guidelines of venetoclax, with dose escalation up to 400 mg. To minimize the risk of tumor lysis syndrome (TLS), and following the package insert directions for dose escalation over 5 weeks, the initial dose is 20 mg daily, and may be progressively increased as tolerated to 400 mg by week 5.

Study Details

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.

Key Dates

Start date
Jan 15, 2020
Status verified
Jun 2021
Primary completion
Feb 10, 2021
Completion
Jun 22, 2021

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ABT-199 (Venetoclax)
    Patients with Cutaneous T Cell Lymphoma (CTCL) will receive ABT-199 (Venetoclax).

Primary Outcome Measure

Body Temperature [ Time Frame: Up to 32 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven Hospital / Smilow Cancer CenterNew HavenConnecticut06520-

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Yale New Haven Hospital / Smilow Cancer Center· New Haven, CT

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