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Clinical Trials in Japan / NCT06067347
Recruiting Observational

A Global Study of the PETAL Consortium

NCT06067347 · tracked via the Priya Life Science Japan tracker
Sponsor
Massachusetts General Hospital
Phase
Observational
Started
2024-01-05
Last updated
2026-04-09

Condition(s) studied

T-Cell and NK-Cell Neoplasm

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Overall Survival — 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.
  • Progression-free Survival — 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.
  • Duration of Response — 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.
  • Time to progression — 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.
  • Number of subjects proceeding to stem cell transplantation — 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.
  • Association of tumor specific somatic variants with treatment response — 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.

Trial sites (14)

FacilityCityRegionStatus
City of Hope Duarte California Recruiting
University of Colorado Denver Colorado Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
OhioHealth Columbus Ohio Recruiting
University of Pennsylvania Philadelphia Pennsylvania Recruiting
University of Virginia Charlottesville Virginia Recruiting
Royal Adelaide Hospital Adelaide South Australia Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting
Kyoto University Kyoto Japan Recruiting
University of Cape Town Cape Town South Africa Recruiting

More Massachusetts General Hospital trials in Japan

Massachusetts General Hospital and Tsuchiura Kyodo General Hospital Coronary Imaging Collaboration Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06067347 on ClinicalTrials.gov ↗ ← All trials in Japan