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

Launched by SECURABIO · Jul 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called duvelisib for patients with a type of lymphoma known as nodal T cell lymphoma, specifically those with a T Follicular Helper (TFH) phenotype. The goal is to see if duvelisib can help patients live longer without their disease getting worse compared to standard treatments like gemcitabine or bendamustine, which are commonly used for this type of lymphoma. The trial is currently not recruiting participants, but it will be open to adults aged 65 to 74 who have already tried at least one other treatment that didn't work for them.

To be eligible for the study, participants must have a confirmed diagnosis of nodal T cell lymphoma with the TFH phenotype and have measurable disease that can be tracked. However, those with skin-only lymphoma or who have had certain types of transplants or previous treatments with similar drugs within the last two months won't be able to participate. If you join the trial, you will be closely monitored to see how well the treatment works for you and what side effects, if any, you may experience. This study could help find better options for patients with this challenging condition.

Gender

ALL

Eligibility criteria

• 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.