The objective of this study is to evaluate the efficacy of TQ-B3525 in patients with relapsed / refractory follicular lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.
Objective response rate (ORR) assessed by Independent Review Committee (IRC)
Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.
Time frame: Baseline up to 18 months
Progression-free survival (PFS)
PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.
Time frame: Baseline up to 18 months
Overall response rate (ORR) assessed by investigator
Percentage of subjects achieving complete response (CR) and partial response (PR) based on investigator.
Time frame: Baseline up to 18 months
Disease control rate(DCR)
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: Baseline up to 18 months
Overall Survival (OS)
OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
Time frame: Baseline up to 24 months
Disease control rate (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Time frame: Baseline up to 18 months
Safety
AE, ADR, and SAE, and withdrawal from the trial for reasons such as safety or tolerability.
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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
NOT_YET_RECRUITINGBeijing Luohe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Shijitan Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGChinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGFifth Medical Center of General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGPeking University People's Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe Sixth Medical Center of General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGXuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITING...and 31 more locations
Time frame: Baseline up to 18 months
Biomarkers
To assess the changes of genes related to PI3K pathway and bypass in the tissues and / or plasma of enrolled patients.
Time frame: Baseline up to 18 months