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A Global Study of the PETAL Consortium

NCT06067347 · Massachusetts General Hospital
In plain English

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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
About this study
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.
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.
Study design
Enrollment target: 1200 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-01-05
Estimated completion: 2028-01
Last updated: 2026-04-09
Primary outcomes
  • Overall Survival (Up to 4 Years)
  • Progression-free Survival (Up to 4 Years)
  • Duration of Response (Up to 4 Years)
Sponsor
Massachusetts General Hospital · other
Contacts & investigators
ContactSalvia Jain, MD · contact · salvia.jain@mgh.harvard.edu · 650-224-0183
ContactForum Bhanushali · contact · fbhanushali@bwh.harvard.edu · 857-757-0966
All locations (14)
City of HopeRecruiting
Duarte, California, United States
University of ColoradoRecruiting
Denver, Colorado, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
OhioHealthRecruiting
Columbus, Ohio, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
University of VirginiaRecruiting
Charlottesville, Virginia, United States
Royal Adelaide HospitalRecruiting
Adelaide, South Australia, Australia
Peter MacCallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
Kyoto UniversityRecruiting
Kyoto, Japan
University of Cape TownRecruiting
Cape Town, South Africa, South Africa
A Global Study of the PETAL Consortium · TrialPath