A Global Study of the PETAL Consortium (PETAL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: T-Cell and NK-Cell Neoplasm

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.

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Salvia Jain, MD; Phone Number: 650-224-0183; Email: salvia.jain@mgh.harvard.edu
• Study Contact Backup: Name: Forum Bhanushali; Phone Number: 857-757-0966; Email: fbhanushali@bwh.harvard.edu

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Royal Adelaide Hospital
      • Contact: Danielle Blunt Site Investigator, MD; Phone Number: +61 8 7074 0000; Email: Danielle.Blunt@sa.gov.au
      • Principal Investigator: Danielle Blunt, MD
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Recruiting
      • Peter MacCallum Cancer Centre
      • Contact: Carrie Van Der Weyden, MD; Phone Number: +03-8559-5000; Email: Carrie.VanDerWeyden@petermac.org
      • Principal Investigator: Carrie Van Der Weyden, MD
• Japan
  • Kyoto, Japan, 606-8501
    • Recruiting
    • Kyoto University
    • Contact: Takashi Sakamoto, MD; Phone Number: +81 75-753-7531; Email: tsakamo@kuhp.kyoto-u.ac.jp
    • Principal Investigator: Takashi Sakamoto, MD
• South Africa
  • South Africa
    • Cape Town, South Africa, South Africa, 7700
      • Recruiting
      • University of Cape Town
      • Contact: Estelle Verburgh, MD; Phone Number: +27 21 650 9111; Email: estelle.verburgh@uct.ac.za
      • Principal Investigator: Estelle Verburgh, MD
• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope
      • Principal Investigator: Christina Poh, MD
      • Contact: Christina Poh Site Investigator, MD; Phone Number: (877) 302-3373; Email: cpoh@coh.org
  • Colorado
    • Denver, Colorado, United States, 80204
      • Recruiting
      • University of Colorado
      • Principal Investigator: Bradley Haverkos, MD
      • Contact: Phone Number: (303) 315-5969; Email: bradley.haverkos@cuanschutz.edu
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Principal Investigator: Yumeng Zhang, MD
      • Contact: Yumeng Zhang, MD; Phone Number: (888) 663-3488; Email: Yumeng.Zhang@Moffitt.org
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Salvia Jain, MD
      • Contact: Salvia Jain, MD; Phone Number: 650-224-0183; Email: salvia.jain@mgh.harvard.edu
      • Contact: Forum Bhanushali; Phone Number: 857-757-0966; Email: fbhanushali@bwh.harvard.edu
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Principal Investigator: Eric Jacobsen, MD
      • Contact: Eric Jacobsen, MD; Phone Number: 877-442-3324; Email: eric_jacobsen@dfci.harvard.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Nora Bennani, MD; Phone Number: (507) 284-2511; Email: Bennani.Nora@mayo.edu
      • Principal Investigator: Bennani Nora, MD
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Hackensack University Medical Center
      • Principal Investigator: Tatyana Feldman, MD
      • Contact: Tatyana Feldman, MD; Phone Number: (201) 996-4300; Email: tatyana.feldman@hmhn.org
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Recruiting
      • OhioHealth
      • Principal Investigator: Basem William, MD
      • Contact: Basem William Site Investigator, MD; Phone Number: (614) 544-4483; Email: Basem.William@ohiohealth.com
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Principal Investigator: Stefan Barta, MD
      • Contact: Stefan Barta, MD; Phone Number: 215-898-5000; Email: stefan.barta@pennmedicine.upenn.edu
  • Virginia
    • Charlottesville, Virginia, United States, 22903-4
      • Recruiting
      • University of Virginia
      • Principal Investigator: Enrica Marchi, MD
      • Contact: Enrica Marchi, MD; Phone Number: +1 434-924-0311; Email: EM5YT@uvahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Massachusetts General Hospital, Boston, USA; Participating investigators at various institutions will perform weekly review of their new patients with PTCL (newly diagnosed or relapsed/refractory) on the outpatient and inpatient clinical services with their clinical research teams to identify potential subjects for enrollment based on the above inclusion/exclusion criteria. Expected enrollment is anticipated to be up to 50 patients per site per year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Difference in overall survival (OS) in subjects with primary refractory versus relapsed mature T-cell and NK-cell neoplasms at the completion of 4 years.	Up to 4 Years
Progression-free Survival	Difference in progression-free survival (PFS) in subjects with primary refractory versus relapsed mature T-cell and NK-cell neoplasms at the completion of 4 years.	Up to 4 Years
Duration of Response	Difference in duration of response in subjects with mature T-cell and NK-cell neoplasms treated with cytotoxic chemotherapy versus prespecified non-chemotherapeutic choice at the completion of 4 years.	Up to 4 Years
Time to progression	Difference in time to progression in subjects with mature T-cell and NK-cell neoplasms treated with cytotoxic chemotherapy versus prespecified non-chemotherapeutic choice at the completion of 4 years.	Up to 4 Years
Number of subjects proceeding to stem cell transplantation	Difference in number of subjects bridged to stem cell transplantation (allogeneic or autologous) with mature T-cell and NK-cell neoplasms treated with cytotoxic chemotherapy versus prespecified non-chemotherapeutic choice at the completion of 4 years.	Up to 4 Years
Association of tumor specific somatic variants with treatment response	Determine whether tumor specific somatic variants identified at the time of diagnosis predicts response to treatment in subjects with mature T-cell and NK-cell neoplasms at the completion of 4 years in at least 50% of the patients.	Up to 4 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response Rate	Difference in complete response rate in subjects with mature T-cell and NK-cell neoplasms treated with cytotoxic chemotherapy versus prespecified non-chemotherapeutic choice.	Up to 4 Years
Overall Response Rate	Difference in overall response rate in subjects with mature T-cell and NK-cell neoplasms treated with cytotoxic chemotherapy versus prespecified non-chemotherapeutic choice.	Up to 4 Years
Rate of Adverse Events	Frequency of adverse events in subjects with mature T-cell and NK-cell neoplasms treated with cytotoxic chemotherapy versus prespecified non-chemotherapeutic choice using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	Up to 4 Years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of overall survival	Feasibility of Synthetic Intervention of estimating difference in overall survival as measured by the ability to predict overall survival in subjects with mature T-cell and NK-cell neoplasms treated with cytotoxic chemotherapy versus prespecified non-chemotherapeutic choice.	Up to 4 Years
FACT-Lym	Define overall health-related quality of life as measured by the Functional Assessment of Cancer Therapy [FACT-Lym] in in subjects with mature T-cell and NK-cell neoplasms. 5-point Likert, measures 4 domains including physical, social, emotional, and functional. Ranges from 0-168, with higher scores indicating better quality of life.	Up to 4 Years
FACIT-COST	Characterize the association between health-related quality of life as measured by the Functional Assessment of Cancer Therapy [FACT-Lym] and poverty as measured by the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for Financial Toxicity [FACIT-COST] and by the Health Leads Social Needs Screening Toolkit in subjects with mature T-cell and NK-cell neoplasms. 5-point Likert with the range of 0-44, with higher scores indicate better financial well-being.	Up to 4 Years
HADS	Describe the prevalence of psychological distress as measured by the Hospital Anxiety and Depression Scale [HADS] in subjects with mature T-cell and NK-cell neoplasms and examine whether psychological distress is associated with disease characteristics. Ranges from 0-21, with higher scores indicating higher distress (anxiety, depression).	Up to 4 Years
IES-R	Describe the prevalence of the Impact of Event Scale-Revised [IES-R] in subjects with mature T-cell and NK-cell neoplasms and examine whether psychological distress is associated with disease characteristics and measures subjective reaction after a traumatic event. Ranges from 0-88, with higher scores indicating likely presence of PTSD.	Up to 4 Years
Household Material Hardship (HMH)	Define the prevalence of household material hardship as measured by the Health Leads Social Needs and examine the association between household material hardship and health-related quality of life (FACT-Lym) in subjects with mature T-cell and NK-T cell neoplasms. Measures unmet concrete needs across 5 domains - housing, utility, food, transportation, interpersonal safety. Binary: no (0) or yes (1). Yes, means a positive screen with higher scores indicate greater material hardship.	Upto 4 Years
Kessler Psychological Distress Scale - K10	Define the prevalence of psychological distress as measured by the Kessler-10 in subjects with mature T-cell and NK-T cell neoplasms and examine whether psychological distress is associated with disease characteristics. 5-point Likert with the range of 0-24, with higher scores suggesting serious PD (psychological distress) or higher likelihood of diagnosable mental illness.	Upto 4 Years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 23-212

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No