The goal of this clinical trial is to evaluate the efficacy and safety of Lacutoclax, an oral selective BCL-2 inhibitor, in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Lacutoclax is a potent and selective BCL-2 inhibitor with relatively weaker inhibitory activity against BCL-XL and BCL-W. Preliminary clinical data have demonstrated promising efficacy and an acceptable safety profile in patients with CLL/SLL and other B-cell non-Hodgkin lymphomas (B-NHLs). This is an open-label, single-arm, multicenter Phase II study evaluating the efficacy and safety of oral Lacutoclax tablets in patients with relapsed or refractory CLL/SLL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Participants will first undergo a dose ramp-up period of at least 4 days (Cycle 0: C0D1-C0D4), followed by continuous administration at the target dose of 400 mg once daily starting from Cycle 1. Each treatment cycle will last 28 days. Treatment will continue until disease progression, unacceptable toxicity, or fulfillment of other criteria for treatment discontinuation.
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGOverall Response Rate (ORR) assessed by Independent Review Committee (IRC)
Time frame: Up to approximately 28 months
ORR assessed by Investigator(INV)
Time frame: Up to approximately 28 months
Complete response(CR) plus complete response with incomplete bone marrow recovery (CRi) rate (CRi applicable only to patients with CLL) assessed by IRC and INV, respectively
Time frame: Up to approximately 28 months
Time to response (TTR) assessed by IRC and INV, respectively
Time frame: Up to approximately 30 months
Duration of response (DOR) assessed by IRC and INV, respectively
Time frame: Up to approximately 30 months.
Time to first 50% reduction in absolute lymphocyte count (ALC) or normalization of ALC
Time frame: Up to approximately 28 months
Progression-free survival (PFS) assessed by IRC and INV, respectively
Time frame: Up to approximately 30 months
Overall Survival
Time frame: Up to approximately 30 months
Adverse events(AEs) as assessed by CTCAE v5.0
Time frame: Up to approximately 30 months
Adverse drug reactions (ADRs) related to Lacutoclax
Time frame: Up to approximately 30 months
Serious adverse events (SAEs)
Time frame: Up to approximately 30 months
Maximum Plasma Concentration(Cmax)
Time frame: From 1 hour prior to administration to 24 hours post-dose
Time to Maximum Plasma Concentration (Tmax)
Time frame: From 1 hour prior to administration to 24 hours post-dose
Half-life (T1/2)
Time frame: From 1 hour prior to administration to 24 hours post-dose
Area Under the Plasma Concentration-Time Curve from Time Zero to Time t(AUC0-t)
Time frame: From 1 hour prior to administration to 24 hours post-dose
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