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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2022
  • participants needed
    18
  • sponsor
    Yale University
Updated on 20 January 2021
platelet count
metastases
lymphoma
systemic therapy
serum pregnancy test
treatment regimen
vorinostat
neutrophil count
sezary syndrome
romidepsin
extracorporeal photopheresis
mycosis
bexarotene
puva
electron beam therapy

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.

Description

This is a single arm, open-label, non-randomized study with venetoclax (ABT-199) in CTCL patients (subtypes mycosis fungoides and Szary 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.

Details
Treatment ABT-199 (venetoclax)
Clinical Study IdentifierNCT04171791
SponsorYale University
Last Modified on20 January 2021

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have cutaneous T-cell lymphoma?
Do you have any of these conditions: Do you have cutaneous T-cell lymphoma??
Biopsy-confirmed CTCL (subtypes mycosis fungoides and Szary syndrome only, and excluding transformed mycosis fungoides), stage IB-IV (hereafter referred to as advanced stage). An off-site biopsy report confirming CTCL diagnosis is acceptable
All subjects must have shown disease refractory to one or more standard systemic therapy (PUVA, oral bexarotene, vorinostat, romidepsin, and/or Photopheresis) and/or total skin electron beam therapy over 3 months, or have demonstrated relapsed or progressive disease at any time while receiving one or more of therapies
Eastern Cooperative Oncology Group (ECOG) Performance Status of 2
Adequate bone marrow function: WBC > 2000/L; platelet count > 75,000/mm3; Neutrophil count > 1000/L, without use of colony stimulating factors (CSF)
Required washout period for prior therapies
Spot Skin Radiation Therapy (10% skin surface): 4 weeks
Systemic therapy: 4 weeks, or until recovered from toxicities
Women of child-bearing potential must have negative serum pregnancy test and use accepted highly effective methods of birth control throughout the study and for 90 days after dosing and must agree to use effective contraception, such as hormonal birth control (must be at least 3 years without complications), intrauterine devices, double barrier method (condom plus spermicide or diaphragm), or abstain from sexual intercourse
Male patients must be willing to use an appropriate method of contraception (e.g., condoms) or abstain from sexual intercourse and inform any sexual partners that they must also use a reliable method of contraception during the study and for 90 days after dosing
Adequate hepatic function: bilirubin 1.5 x upper limit of normal (ULN), AST 3.0 x ULN, ALT 3.0 x ULN
Adequate renal function: creatinine clearance 50 mL/min
Ability to comply with the treatment schedule

Exclusion Criteria

Extracutaneous disease except blood, bone marrow and lymph nodes
Concomitant use of any systemic anti-cancer therapy or immune modifier
Concomitant use of moderate or strong CYP3A inhibitors or inducers within 1 week of initiation of study drug administration
Patients receiving P-gp inhibitors are not eligible for inclusion unless these agents are discontinued for a washout period of 4 weeks. Patients who are taking medications that are narrow window index P-gp substrates (e.g. digoxin, fexofenadine, loperamide, quinidine, talinolol, vinblastine) are not eligible for enrollment
Patients with biopsy confirmed transformed MF
Prior allogeneic hematopoietic cell transplant
Any ongoing infection requiring antibiotics within 2 weeks prior to the start of the study drug, except for antibiotics (e.g. cephalexin) prescribed superficial skin infection
Known history of human immunodeficiency virus (HIV), hepatitis B or C
History of prior malignancy with the exception of cervical intraepithelial neoplasia, non-melanoma skin cancer, and adequately treated localized prostate carcinoma (PSA <1.0). Patients with a history of other malignancies must have undergone potentially curative therapy and have no evidence of that disease for five years
Uncontrolled intercurrent illness, condition, or circumstances that could limit compliance with the study including, but not limited to, the following: acute or chronic graft versus host disease, uncontrolled diabetes mellitus or hypertension, or psychiatric conditions
Major surgery within 8 weeks of enrollment
Medically significant cardiac event or unstable cardiovascular function defined as
Symptomatic ischemia, unstable angina pectoris
Uncontrolled clinically significant cardiac arrhythmia
Symptomatic heart failure NYHA Class 3
Myocardial infarction or cardiac surgery within 6 months prior to enrollment
Cerebrovascular event (transient ischemic attack, stroke or CNS bleeding) within the last 12 months
Major bleeding within the last 6 months
Use of any investigational agents within 30 days prior to enrollment and for the duration of the study
Pregnant or lactating
Unwilling or unable to provide informed consent
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