A Randomized Phase II Study of CHO(E)P vs CC-486-CHO(E)P vs Duvelisib-CHO(E)P in Previously Untreated CD30 Negative Peripheral T-Cell Lymphomas
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/CLL (ONC)
Current Status: Open
Phase: II (Cancer Control) (Cancer Prevention)
Principal Investigator: Lunning, Matthew
Eligibility: https://clinicaltrials.gov/ct2/show/NCT04803201?term=NCT04803201&draw=2&rank=1#eligibility
Summary
2.1 Primary objective
To compare the complete remission (CR) rates by FDG PET/CT using the Lugano 2014 criteria following completion of treatment with duvelisib-CHO(E)P vs CHO(E)P and with CC-486- CHO(E)P vs CHO(E)P in previously untreated peripheral T-cell lymphomas that have < 10% expression of CD30.
2.2 Secondary objective(s)
2.2.1 To determine the toxicity and tolerability of the treatment regimens.
2.2.2 To determine the complete remission (CR) rates by FDG PET/CT or CT alone using the Lugano 2014 criteria.
2.2.3 To determine the overall response rate (ORR), duration of response, progression free survival (PFS), event free survival (EFS), and overall survival (OS) of each treatment regimen.
2.2.4 To determine whether designation of follicular helper T-cell phenotype is correlated with response to therapy, PFS, EFS, and OS.
2.2.5 To assess the toxicity profile of the experimental regimens in untreated CD30 negative peripheral T-cell lymphomas using CTCAE and PRO-CTCAE