The purpose of this study is to evaluate the efficacy and safety of SHC014748M in patients with relapsed or refractory relapsed or refractory follicular (FL) or marginal one (MZL) lymphoma.
This is a phase II, multicenter study to assess the efficacy and safety of SHC014748M, an oral inhibitor of PI3K delta, in patients with relapsed or refractory relapsed or refractory follicular (FL) or marginal one (MZL) lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
122
Each treatment cycle is comprised of 28-day consecutive dosing of SHC014748M, 200mg QD (Days 1 to28). Upon completion of each cycle, patients may continue to receive oral SHC014748M if they can benefit from the treatment and the toxicity is tolerable.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGThe First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGObjective Response Rate (ORR)
Proportion of patients who have either a complete or partial response before any treatment change.
Time frame: up to 12 months
Lymph Node Response (LNR)
LNR was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the product of the perpendicular diameters (SPD) of measurable index lesions.
Time frame: up to 12 months
Time to Response (TTR)
TTR was defined as the interval from the start of SHC014748M treatment to the first documentation of complete response(CR) or partial response(PR).
Time frame: up to 12 months
Progression-Free Survival (PFS)
PFS was defined as the interval from the start of SHC014748M treatment to the earlier of the first documentation of disease progression or death from any cause. PFS was analyzed using Kaplan-Meier (KM) estimates.
Time frame: up to 12 months
Duration of Response (DOR)
DOR was defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression as or death from any cause. DOR was analyzed using KM estimates.
Time frame: up to 12 months
Mean Change From Baseline in the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Scale.
The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on health related quality of life(HRQL) and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess non-Hodgkins lymphoma(NHL) related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a better quality of life.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 12 months
Safety and Tolerability of SHC014748M Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms.
Time frame: up to 12 months
Pharmacokinetics Parameter: Cmax
Time frame: 4 weeks
Pharmacokinetics Parameter: Tmax
Time frame: 4 weeks
Pharmacokinetics Parameter: ACUlast
Time frame: 4 weeks