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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06067347




Registration number
NCT06067347
Ethics application status
Date submitted
5/09/2023
Date registered
4/10/2023
Date last updated
10/04/2025

Titles & IDs
Public title
A Global Study of the PETAL Consortium
Scientific 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
Secondary ID [1] 0 0
23-212
Universal Trial Number (UTN)
Trial acronym
PETAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
T-Cell and NK-Cell Neoplasm 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Up to 4 Years
Primary outcome [2] 0 0
Progression-free Survival
Timepoint [2] 0 0
Up to 4 Years
Primary outcome [3] 0 0
Duration of Response
Timepoint [3] 0 0
Up to 4 Years
Primary outcome [4] 0 0
Time to progression
Timepoint [4] 0 0
Up to 4 Years
Primary outcome [5] 0 0
Number of subjects proceeding to stem cell transplantation
Timepoint [5] 0 0
Up to 4 Years
Primary outcome [6] 0 0
Association of tumor specific somatic variants with treatment response
Timepoint [6] 0 0
Up to 4 Years
Secondary outcome [1] 0 0
Complete Response Rate
Timepoint [1] 0 0
Up to 4 Years
Secondary outcome [2] 0 0
Overall Response Rate
Timepoint [2] 0 0
Up to 4 Years
Secondary outcome [3] 0 0
Rate of Adverse Events
Timepoint [3] 0 0
Up to 4 Years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2028
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
Japan
State/province [3] 0 0
Hyogo

Funding & Sponsors
Primary sponsor type
Other
Name
Massachusetts General Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Salvia Jain, MD
Address 0 0
Country 0 0
Phone 0 0
650-224-0183
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06067347