A Global Study of the PETAL Consortium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: T-Cell and NK-Cell Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Japan, South Africa
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The goal of this observational study is to correlate molecular alterations with outcomes including overall survival (OS), progression-free survival (PFS), response rates for patients with a new diagnosis, primary refractory or relapse, of mature T-cell and NK-cell neoplasms (TNKL). We hypothesize that machine learning can be leveraged to uncover distinct genetic vulnerabilities that underlie treatment response and resistance for patients with TNKL, thus moving towards personalized treatment solutions.
Detailed description
This study is a prospective, longitudinal observational study of patients with newly diagnosed or relapsed/refractory T-cell and NK-cell neoplasms, conducted across multiple participating institutions globally. Patients will be enrolled during their initial visit as new patients and will be followed for up to four years through the course of their clinical management. Data for routine demographics, baseline clinical features, including pathology, molecular information related to the tumor, radiology, treatment characteristics and quality of life (QoL) associated with their lymphoma care will be collected over the course of 4 years by clinical research teams at every participating institution. The de-identified data will be securely shared through a password protected REDCap with other participating institutions under data usage agreements of the consortium. Next generation sequencing (NGS) including but not limited to whole exome sequencing and bulk RNA-sequencing will be performed on archived lymphoma specimens, mononuclear cells, cfDNA and saliva (when feasible) for a comprehensive molecular characterization of the tumor. Molecular data will be analyzed in correlation with patient outcomes. Advanced deep learning algorithms will be applied to predict responses and survival across lymphoma subtypes, heterogeneous clinical scenarios and various potential therapeutic approaches that the patient has not been exposed to.
Primary outcome measures
- Overall Survival [Time frame: Up to 4 Years]
- Progression-free Survival [Time frame: Up to 4 Years]
- Duration of Response [Time frame: Up to 4 Years]
- Time to progression [Time frame: Up to 4 Years]
- Number of subjects proceeding to stem cell transplantation [Time frame: Up to 4 Years]
- Association of tumor specific somatic variants with treatment response [Time frame: Up to 4 Years]
Secondary outcome measures (3)
- Complete Response Rate [Time frame: Up to 4 Years]
- Overall Response Rate [Time frame: Up to 4 Years]
- Rate of Adverse Events [Time frame: Up to 4 Years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 10 centers
- City of Hope — Duarte
- University of Colorado — Denver
- Moffitt Cancer Center — Tampa
- Massachusetts General Hospital — Boston
- Dana-Farber Cancer Institute — Boston
- Mayo Clinic — Rochester
- Hackensack University Medical Center — Hackensack
- OhioHealth — Columbus
- … and 2 more centers
Australia · 2 centers
- Royal Adelaide Hospital — Adelaide
- Peter MacCallum Cancer Centre — Melbourne
Japan · 1 center
- Kyoto University — Kyoto
South Africa · 1 center
- University of Cape Town — Cape Town
Identifiers
NCT: NCT06067347 · 23-212