The study will evaluate the progression-free survival benefit of duvelisib monotherapy as compared to investigator's choice of gemcitabine or bendamustine in participants with relapsed/refractory nodal T cell lymphoma with TFH phenotype.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
oral capsules
solution for intravenous infusion
solution for intravenous infusion
Progression-free Survival (PFS) as assessed by the Independent Review Committee (IRC)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
PFS as assessed by the investigator
Time frame: Up to 3 years
Objective Response Rate (ORR) as assessed by the IRC
Time frame: Up to 3 years
Complete Response Rate (CRR) as assessed by the IRC
Time frame: Up to 3 years
Duration of Response (DOR) as assessed by the IRC
Time frame: Up to 3 years
Proportion of participants who proceed to Stem Cell Transplantation (SCT)
Time frame: Up to 3 years
Investigator-assessed PFS in participants who proceed to SCT
Time frame: Up to 3 years
Number of participants with Adverse Events (AEs)
Time frame: Up to 3 years
Quality of Life (QoL): European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score
Time frame: Up to 3 years
QoL: EQ5D Score
Time frame: Up to 3 years
QoL: QLQ-NHL-HG29 Score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitair Ziekenhuis Gent (UZ Gent)
Ghent, Belgium
NOT_YET_RECRUITINGUZ Leuven - Gasthuisberg Campus
Leuven, Belgium
RECRUITINGVseobecna fakultni nemocnice
Prague, Czechia
RECRUITINGAarhus University Hospital
Aarhus, Denmark
NOT_YET_RECRUITINGRigshospitalet Copenhagen
Copenhagen, Denmark
RECRUITINGOdense Hospital
Odense, Denmark
RECRUITINGUNICANCER - Centre Henri-Becquerel
Rouen, Normandy, France
NOT_YET_RECRUITINGInstitut Gustave Roussy
Villejuif, Vaillant, France
RECRUITINGCHU Cote de Nacre
Caen, France
NOT_YET_RECRUITINGCHU Clermont-Ferrand
Clermont-Ferrand, France
RECRUITING...and 33 more locations
Time frame: Up to 3 years
Concentration of Duvelisib and its Metabolites in Blood
Time frame: Day 1 of Cycle 1 and Cycle 2 (predose and 60 minutes postdose)