This study examined the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability.
This was a Phase 2, randomized, open-label, 2-arm study designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in participants with relapsed or refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) who have received at least 1 prior systemic therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
Phosphoinositide 3-kinase (PI3K) inhibitor
Overall Response Rate (ORR) According to the 2007 Revised International Working Group (IWG) Criteria
ORR was defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and assessed using the 2007 revised IWG criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites.
Time frame: Up to 14 months
Progression-free Survival (PFS)
PFS was defined as the time from first dose to first progressive disease (PD) or death (progression date/death date - treatment start date + 1) or, for participants without PD or documented death, as the time from first dose to censoring date (censoring date - treatment start date + 1). The 2007 revised IWG criteria defined PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined PD as a progressive metabolic response (according to positron emission tomography-computed tomography \[PET-CT\]) and progressive disease (according to computed tomography \[CT\]). Results reported as months.
Time frame: Up to 2 years
ORR At Specific Timepoints
ORR at 6, 12, 18, and 24 months after first dose of study intervention was defined as the percentage of participants achieving CR or PR at each timepoint and was assessed using both the 2007 revised IWG criteria and the 2014 Lugano criteria. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). The response was cumulative for each timepoint; a participant was considered a responder if their first response occurred up to the end of that timepoint.
Time frame: 6, 12, 18, and 24 months after first dose of study intervention
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Florida Cancer Specialists - Fort Myers
Fort Myers, Florida, United States
Florida Cancer Specialists & Research Institute - Lecanto
Lecanto, Florida, United States
Mid-Florida Cancer Centers
Orange City, Florida, United States
Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Tennessee Oncology
Nashville, Tennessee, United States
FN Hradec Kralove
Hradec Králové, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Universitaetsklinikum Bonn AöR
Bonn, Germany
Oncology Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori
Meldola, Forli, Italy
...and 18 more locations
Duration of Response (DOR)
DOR was defined for participants with CR or PR as the time from the date of first documentation of response (CR or PR) to date of the first documentation of PD or death. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease, PR as the regression of measurable disease and no new sites, and PD as any new lesion or increase by ≥50% of previously involved sites from nadir. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT), PR as partial metabolic response (according to PET-CT) and partial remission (according to CT), and PD as a progressive metabolic response (according to PET-CT) and progressive disease (according to CT). Results are reported as months.
Time frame: Up to 2 years
Overall Survival (OS)
OS was the time from first dose to death (death date - treatment start date + 1). Participants without documented death were censored at their last known alive date (last known alive date - treatment start date + 1). Results reported as months.
Time frame: Up to 2 years
Lymph Node Response Rate (LNRR)
LNRR was calculated as the percentage of participants achieving ≥50% decrease in the sum of the product of the diameters of target lymph nodes. The confidence interval for LNRR was calculated only for participants who had at least 1 nodal target lesion, using the Clopper-Pearson exact method for binomial proportions. Participants whose target lesions were all extranodal were excluded from this analysis.
Time frame: 14 months
Time To First Response (TTFR)
For participants with CR or PR, TTFR was defined as the time from first dose of study intervention to time of first CR or PR and was calculated as: the date of first CR or PR - randomization date + 1. The 2007 revised IWG criteria defined CR as the disappearance of all evidence of disease and PR as the regression of measurable disease and no new sites. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT). Results are reported as months.
Time frame: Up to 14 months
Time To Treatment Failure (TTF)
TTF was calculated as the time from first dose of study treatment to discontinuation for any reason (discontinuation date - treatment start date + 1). Participants who were still ongoing treatment at time of data cut were censored (last dose date - treatment start date + 1). Results reported as months.
Time frame: Up to 2 years
ORR According to 2014 Lugano Criteria
ORR was defined as the percentage of participants achieving a CR or PR and was assessed using the 2014 Lugano criteria. The 2014 Lugano criteria defined CR as a complete metabolic response (according to PET-CT) and a complete radiologic response (according to CT) and PR as partial metabolic response (according to PET-CT) and partial remission (according to CT).
Time frame: Up to 14 months