Observational study on T-Cell and NK-Cell Neoplasms

Integration of Machine Learning and Genomics to Predict Outcomes for Newly Diagnosed, Relapsed and Refractory Mature T-cell and NK/T-cell Lymphomas: a Global Study of the PETAL Consortium

This study looks at how changes in genes affect survival and treatment responses in people with newly diagnosed or relapsed T-cell and NK-cell cancers over four years.

Quick facts

• Study type: Observational
• Enrollment: 1200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Massachusetts General Hospital (other)
• Locations: 14 sites (Duarte, California and 13 other locations)
• Trial ID: NCT06067347 on ClinicalTrials.gov

What this trial studies

This observational study aims to correlate molecular alterations with clinical outcomes such as overall survival and progression-free survival in patients with newly diagnosed or relapsed/refractory T-cell and NK-cell neoplasms. It will follow patients for up to four years, collecting data on demographics, clinical features, molecular information, and quality of life. Advanced machine learning techniques will be utilized to analyze the data and predict treatment responses and survival outcomes based on genetic vulnerabilities. The study will involve multiple institutions globally, ensuring a comprehensive approach to understanding these complex conditions.

Who should consider this trial

Good fit: Ideal candidates include adults with untreated, relapsed, or refractory histologically confirmed mature T-cell or NK-cell neoplasms.

Not a fit: Patients with precursor T/NK neoplasms, certain types of cutaneous T-cell lymphoma, or those unable to consent will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to personalized treatment strategies for patients with T-cell and NK-cell neoplasms, improving their outcomes.

How similar studies have performed: Other studies utilizing machine learning for molecular characterization in cancer have shown promise, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Untreated, relapsed, or refractory histologically confirmed mature T-cell or NK-cell neoplasm.
* 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:

* 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.
* Adults who are unable to consent, individuals who are not yet adults such as infants, children and teenagers, pregnant women, and prisoners.

Where this trial is running

Duarte, California and 13 other locations

• City of Hope — Duarte, California, United States (RECRUITING)
• University of Colorado — Denver, Colorado, United States (RECRUITING)
• Moffitt Cancer Center — Tampa, Florida, United States (RECRUITING)
• Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
• Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
• Hackensack University Medical Center — Hackensack, New Jersey, United States (RECRUITING)
• OhioHealth — Columbus, Ohio, United States (RECRUITING)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
• University of Virginia — Charlottesville, Virginia, United States (RECRUITING)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia (RECRUITING)
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (RECRUITING)
• Kyoto University — Kyoto, Japan (RECRUITING)
• University of Cape Town — Cape Town, South Africa, South Africa (RECRUITING)

Study contacts

• Study coordinator: Salvia Jain, MD

Conditions: T-Cell and NK-Cell Neoplasm