RecruitingPhase IIEN original

A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek co najmniej 18 lat
  • •Potwierdzony rozpoznaniem chłoniaka T-komórkowego skóry (CTCL) na podstawie badania histologicznego
  • •Zaawansowana choroba (co najmniej stadium Ib)
  • •Brak odpowiedzi na co najmniej 2 poprzednie leczenia lub nietolerancja ich
  • •Mierzalne ogniska choroby widoczne w badaniach
  • •Zdrowe funkcje szpiku kostnego, wątroby i nerek
  • •Ujemny wynik testu na HTLV-1
  • •Oczekiwana długość życia co najmniej 3 miesiące

✗ Disqualifies

  • •Aktualnie w ciąży lub karmieniu piersią
  • •Dodatni wynik testu na HIV bez stabilnego leczenia lub z wiremią powyżej 400 kopii/mL
  • •Niedawne leczenie przeciwnowotworowe (brak wymaganego okresu przerwy)

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
September 9, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (15)

City of Hope Comprehensive Cancer Cente

Duarte, United States

University of California Irvine

Irvine, United States

Yale Cancer Center

New Haven, United States

Dana-Farber Cancer Institute

Boston, United States

Rochester Skin Lymphoma Medical Group. PLLC

Rochester, United States

Virginia Commonwealth University Massey Comprehensive Cancer Cente

Richmond, United States

Westmead Hospital

Westmead, Australia

Epworth Healthcare

Melbourne, Australia

Linear Clinical Research

Nedlands, Australia

CHU de Bordeaux - Hopital Saint André

Bordeaux, France

Hopital Lyon Sud

Lyon, France

Hopital Saint Louis

Paris, France

IRCCS Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi

Bologna, Italy

Universita degli Studi Di Brescia-Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, Italy

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

Milan, Italy

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/10/2026.

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