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NCT Number: NCT06067347

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.

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Key information

Conditions

T-Cell and NK-Cell Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Adelaide Hospital, Adelaide, South Australia, Australia

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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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Forum Bhanushali

CONTACT

[email protected]

857-757-0966

Salvia Jain, MD

CONTACT

[email protected]

650-224-0183

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study 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

Acronym: PETAL

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 4, 2023
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.