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

NCT04171791 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-06-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ABT-199 (venetoclax)

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.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Michael Girardi, MD, FAAD · Professor of Dermatology Yale University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2021-02-10
Completion
2021-06-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04171791 on ClinicalTrials.gov