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A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype

RecruitingPhase 3Ages 18 Years - anyAllSecuraBio
NCT06522737 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The study will evaluate the progression-free survival benefit of duvelisib monotherapy as compared to investigator's choice of gemcitabine or bendamustine in participants with relapsed/refractory nodal T cell lymphoma with TFH phenotype.

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📋 Eligibility rules (as published)
Key Inclusion Criteria: * Pathologically confirmed nodal T cell lymphoma with TFH phenotype according to the criteria of the World Health Organization classification (Swerdlow 2017, Alaggio 2022) including any one of Angioimmunoblastic T cell lymphoma (AITL), follicular T cell lymphoma, and other nodal peripheral T cell lymphoma (PTCL) with a TFH phenotype. * Relapsed or refractory to at least 1 prior systemic, cytotoxic therapy for T cell lymphoma. * Measurable disease as defined by Lugano 2014 criteria (Cheson 2014) for T cell lymphoma. Key Exclusion Criteria: * Cutaneous-only disease. * Received prior allogeneic transplant any time in the past or received autologous transplant within 60 days prior to the first dose of study drug. * Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor. * Prior exposure to planned study treatment investigator's choice therapy (gemcitabine or bendamustine) within 60 days prior to the first dose of study drug. Other protocol-defined criteria apply.
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What it tests

  • Duvelisib
  • Gemcitabine
  • Bendamustine
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Where

44 sites
Universitair Ziekenhuis Gent (UZ Gent)
Ghent, Belgium
UZ Leuven - Gasthuisberg Campus
Leuven, Belgium
Vseobecna fakultni nemocnice
Prague, Czechia
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet Copenhagen
Copenhagen, Denmark
Odense Hospital
Odense, Denmark
UNICANCER - Centre Henri-Becquerel
Rouen, France
Institut Gustave Roussy
Villejuif, France

…and 36 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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