Clinical trial NCT06067347: A Global Study of the PETAL Consortium
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: T-Cell and NK-Cell Neoplasm
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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 outcomes:
measure: Overall Survival
timeFrame: Up to 4 Years
measure: Progression-free Survival
timeFrame: Up to 4 Years
measure: Duration of Response
timeFrame: Up to 4 Years
measure: Time to progression
timeFrame: Up to 4 Years
measure: Number of subjects proceeding to stem cell transplantation
timeFrame: Up to 4 Years
measure: Association of tumor specific somatic variants with treatment response
timeFrame: Up to 4 Years
Secondary outcomes:
measure: Complete Response Rate
timeFrame: Up to 4 Years
measure: Overall Response Rate
timeFrame: Up to 4 Years
measure: Rate of Adverse Events
timeFrame: Up to 4 Years
Other outcomes:
measure: Estimation of overall survival
timeFrame: Up to 4 Years
measure: FACT-Lym
timeFrame: Up to 4 Years
measure: FACIT-COST
timeFrame: Up to 4 Years
measure: HADS
timeFrame: Up to 4 Years
measure: IES-R
timeFrame: Up to 4 Years
measure: Household Material Hardship (HMH)
timeFrame: Upto 4 Years
measure: Kessler Psychological Distress Scale - K10
timeFrame: Upto 4 Years
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Amagasaki
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center
state: Hyogo
Study officials:
References: