An Open-Label, Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PTX-100 Monotherapy in Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma
This is an open-label, phase 2 randomized study to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmadynamics (PD), of PTX-100 monotherapy at 500 or 1000 mg/m2 in patients with relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL).
PTX-100 will be administered by IV infusion over 60 minutes on days 1 to 5 of a 14-day cycle for 4 cycles, then 21 day cycle thereafter. Subjects will be treated or followed up, if subjects discontinue treatment, for up to 18 months.
Eligibility
You must be ≥18 years of age at the time of signing the informed consent
You cannot participate in this study if you are female who is pregnant or breastfeeding or planning to become pregnant.
Interested in Participating in this Trial?
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Privacy Policy
University of California, Irvine - Study Information Sheet
UCI Center for Clinical Research Potential Participant Database
Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research
In the instance of parental permission, “You” refers to “Your child.”
Please read the information below and ask questions about anything that you do not understand. A
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immediately.
You are eligible to participate in this study if you may be interested in participating in a research trial
at UCI Health
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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your
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Data Retention - In accordance with UC Office of the President policy, information will be retained for
10 years after the end of the calendar year in which the research is completed.
If, during the course of this study, significant new information becomes available that may relate to
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team listed at the top of the form.
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contact the researchers listed at the top of this form
Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at
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