A Global Study of the PETAL Consortium

Trial Title: A Global Study of the PETAL Consortium

NCT ID: NCT06067347

Condition: T-Cell and NK-Cell Neoplasm

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

Summary: The goal of this observational study is to correlate molecular alterations with outcomes including overall survival (OS), progression-free survival (PFS) for patients with a new diagnosis, primary refractory or relapse, of mature T-cell and NK-cell neoplasms (TNKL). We hypothesize that machine learning will uncover distinct genetic vulnerabilties that underlie treatment response and resistance for patient with TNKL.

Detailed description: This study is a prospective longitudinal observational study of newly diagnosed and relapsed/refractory patients with T-cell and NK -cell neoplasm at participating institutions. Patients will be enrolled in the study during the course of their first visit as a new patient at the participating institution and followed for up to 4 years through the course of their clinical management. Routine demographics, baseline clinical features, including pathology, molecular information related to the tumor, radiology, treatment characteristics and quality of life (QoL) related to their lymphoma care will be collected over the course of 4 years by clinical research teams at every participating institution. This data will be de-identified data and then shared through a secure and password protected REDCap with other participating institutions under data usage agreements of the consortium agreement. Next generation sequencing including but not limited to such as whole exome sequencing and bulk RNA-sequencing will be performed on archived lymphoma specimens and on mononuclear cells, cfDNA and saliva (when feasible) for detailed molecular characterization of the tumor. Molecular correlation with outcomes will be performed. Deep learning algorithms will be utilized to predict response and survival of lymphoma subtypes and in heterogeneous clinical scenarios and to various potential therapeutic approaches that the patient has not been exposed to.

Criteria for eligibility:

Study pop:
This is a prospective observational non-interventional study with the primary objective to define overall survival and time to next treatment, as well as determining the ability to bridge patients to stem cell transplantation for patients with a new diagnosis, primary refractory or relapse of T-cell or NK-cell neoplasm.

Sampling method: Non-Probability Sample
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Massachusetts General Hospital

Address:
City: Boston
Zip: 02114
Country: United States

Status: Recruiting

Contact:
Last name: Salvia Jain, MD

Phone: 650-224-0183
Email: salvia.jain@mgh.harvard.edu

Contact backup:
Last name: Olivia Economides, MPH
Email: oeconomides@mgb.org

Start date: January 2024

Completion date: January 2028

Lead sponsor:
Agency: Massachusetts General Hospital
Agency class: Other

Source: Massachusetts General Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06067347