A Global Study of the PETAL Consortium (PETAL)

April 6, 2026 updated by: Salvia Jain, MD, Massachusetts General Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
        • Principal Investigator:
          • Danielle Blunt, MD
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
        • Contact:
        • Principal Investigator:
          • Carrie Van Der Weyden, MD
  • Japan
      • Kyoto, Japan, 606-8501
        • Recruiting
        • Kyoto University
        • Contact:
        • Principal Investigator:
          • Takashi Sakamoto, MD
  • South Africa
    • South Africa
      • Cape Town, South Africa, South Africa, 7700
        • Recruiting
        • University of Cape Town
        • Contact:
        • 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:
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • Yumeng Zhang, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Eric Jacobsen, MD
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Bennani Nora, MD
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • Tatyana Feldman, MD
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • OhioHealth
        • Principal Investigator:
          • Basem William, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Principal Investigator:
          • Stefan Barta, MD
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22903-4
        • Recruiting
        • University of Virginia
        • Principal Investigator:
          • Enrica Marchi, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to 4 Years
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
Time Frame: Up to 4 Years
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
Time Frame: Up to 4 Years
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
Time Frame: Up to 4 Years
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
Time Frame: Up to 4 Years
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
Time Frame: Up to 4 Years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Response Rate
Time Frame: Up to 4 Years
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
Time Frame: Up to 4 Years
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
Time Frame: Up to 4 Years
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Estimation of overall survival
Time Frame: Up to 4 Years
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
Time Frame: Up to 4 Years
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
Time Frame: Up to 4 Years
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
Time Frame: Up to 4 Years
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
Time Frame: Up to 4 Years
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)
Time Frame: Upto 4 Years
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
Time Frame: Upto 4 Years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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