A Study of ABT-199 (Venetoclax) for Cutaneous T Cell Lymphoma (CTCL)
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|ClinicalTrials.gov Identifier: NCT04171791|
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : January 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|CTCL||Drug: ABT-199 (venetoclax)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Open-Label Pilot Study of ABT-199 (Venetoclax) for Cutaneous T Cell Lymphoma (CTCL) Stage IB to IV|
|Estimated Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||February 28, 2021|
|Estimated Study Completion Date :||August 31, 2021|
Experimental: ABT-199 (Venetoclax)
Patients with Cutaneous T Cell Lymphoma (CTCL) will receive ABT-199 (Venetoclax).
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.
- Body Temperature [ Time Frame: Up to 32 weeks ]Safety and tolerability endpoints will be evaluated on the basis of body temperature.
- Blood Pressure- Diastolic [ Time Frame: Up to 32 weeks ]Safety and tolerability endpoints will be evaluated on the basis of blood pressure.
- Blood Pressure- Systolic [ Time Frame: Up to 32 weeks ]Safety and tolerability endpoints will be evaluated on the basis of blood pressure.
- Pulse Rate [ Time Frame: Up to 32 weeks ]Safety and tolerability endpoints will be evaluated on the basis of pulse rate.
- Respiratory Rate [ Time Frame: Up to 32 weeks ]Safety and tolerability endpoints will be evaluated on the basis of respiratory rate.
- Adverse Events [ Time Frame: Up to 32 weeks ]Adverse events will be used to measure the study defined outcome:Toxicity. Toxicity (as adverse events) will measured according to the NCI CTCAE (v5.0) for AEs and clinical laboratory profile; AEs will be collected in all patients who received at least one dose of venetoclax and up to four weeks after last dose (Termination visit).
- Skin Clinical Response [ Time Frame: Up to 32 weeks ]Exploratory skin clinical responses measured by a modified severity-weighted assessment tool (mSWAT).
- Duration of Response [ Time Frame: Up to 32 weeks ]Duration of response to treatment will be measured in weeks.
- Relapse Free and Progression Free Survival [ Time Frame: Up to 32 weeks ]Relapse free and progression free survival based on every 4 week follow up after the initial dose until one of the events occurs first: Progressive disease (PD) is documented, another anticancer treatment is administered and/or 28 weeks are completed after the patient's first dose of venetoclax.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171791
|Contact: Kacie Carlson||(203) firstname.lastname@example.org|
|Contact: Michael Girardi, MD, FAAD||(203) email@example.com|
|United States, Connecticut|
|Yale New Haven Hospital / Smilow Cancer Center||Recruiting|
|New Haven, Connecticut, United States, 06520|
|Contact: Kacie Carlson 203-785-7432 firstname.lastname@example.org|
|Principal Investigator:||Michael Girardi, MD, FAAD||Professor of Dermatology Yale University|