Clinical Trial 23519

• Overview

  Study Title:

  Integration of Machine Learning and Genomics to Predict Outcomes for Newly Diagnosed, Relapsed and Refractory Mature T-Cell and NK-Cell Neoplasms: A Global Study of the PETAL Consortium

  Summary:

  This study looks at how changes in genes are linked to patient outcomes—like how long people live, how long their disease stays under control, and how well they respond to treatment—in people with mature T‑cell and NK‑cell cancers. This includes patients who are newly diagnosed, don’t respond to their first treatment, or whose disease comes back. Investigators believe machine learning can help spot patterns in the genetics that explain why some treatments work and others don’t, which could eventually help tailor treatments to each patient.

  Objective:

  Define overall survival (OS) for patients with newly diagnosed and primary refractory or first relapse treated with a novel agent in the approved or clinical trial setting relative to traditional multiagent chemotherapy. Define time to next treatment (TNT) for patients with newly diagnosed primary and refractory or first relapse of T-cell Lymphoma (TCL) treated with a novel agent in the approved or clinical trial setting relative to traditional multiagent chemotherapy. Determine ability to bridge patients to stem cell transplantation (allogeneic or autologous) for patients with newly diagnosed, primary refractory or first relapse of TCL treated with a novel agent in the approved or clinical trial setting relative to traditional multiagent chemotherapy. Determine relationship between molecular characterization, including genetic sequencing of the lymphoma, clinical outcome, duration of response and progression free survival, and response to therapeutic interventions. Incorporate novel machine learning approaches such as regularized synthetic intervention to predict general clinical and specific therapy related outcomes.

• Inclusion Criteria

  Inclusion Criteria:
  • Patients 18 years or older with untreated, relapsed, or refractory histologically confirmed T-cell or NK-cell will be eligible and enrolled in the study.
  • All subtypes of PTCL are eligible except for T-cell large granular lymphocytic leukemia, cutaneous T-cell lymphoma such as but not limited to mycosis fungoides and transformation, Sézary syndrome, and primary cutaneous CD30+ disorders

• Exclusion Criteria

  Exclusion Criteria:
  • Patients with precursor T/NK neoplasms, T-cell large granular lymphocytic leukemia, cutaneous T-cell lymphoma such as but not limited to mycosis fungoides and transformation, Sézary syndrome, and primary cutaneous CD30+ disorders

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