Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT06067347

Conditions

T-Cell and NK-Cell Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

T-Cell and NK-Cell Neoplasm

Study ID

NCT06067347

Start date

Jan 5, 2024

Status verified date

Apr, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

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.

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Overall Survival [ Time Frame: Up to 4 Years ]
  • Progression-free Survival [ Time Frame: Up to 4 Years ]
  • Duration of Response [ Time Frame: Up to 4 Years ]
  • Time to progression [ Time Frame: Up to 4 Years ]
  • Number of subjects proceeding to stem cell transplantation [ Time Frame: Up to 4 Years ]
  • Association of tumor specific somatic variants with treatment response [ Time Frame: Up to 4 Years ]

Central Contacts and Locations

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Christina Poh Site Investigator, MD

(877) 302-3373cpoh@coh.org

Principal Investigator:

Christina Poh, MD

University of Colorado

Recruiting

Denver, Colorado, United States, 80204

Contacts

Principal Investigator:

Bradley Haverkos, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator:

Yumeng Zhang, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Salvia Jain, MD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator:

Eric Jacobsen, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Bennani Nora, MD

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Principal Investigator:

Tatyana Feldman, MD

OhioHealth

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Basem William Site Investigator, MD

(614) 544-4483Basem.William@ohiohealth.com

Principal Investigator:

Basem William, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Stefan Barta, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903-4

Contacts

Principal Investigator:

Enrica Marchi, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-04-09.