Overview

The Efficacy and Safety of Nelarabine Injection in Patients With T-lymphoblastic Leukemia and T-lymphoblastic Lymphoma

Status:
NOT_YET_RECRUITING

Trial end date:
2026-05-01

Target enrollment:

Participant gender:

Summary

This is a single-arm, open-label, multicenter, phase III clinical study that aims to evaluate the efficacy and safety of Nelarabine injection in the treatment of refractory or recurrent T-lymphoblastic leukemia (T-ALL) and T-lymphoblastic lymphoma (T-LBL) in both children and adults. The trial includes 83 subjects, consisting of 35 adults and 48 children, and aims to evaluate the composite complete response rate (CCR) within 2 cycles, assessed by the Independent Review Committee (IRC), following treatment with Nelarabine injection for children and adults with refractory or recurrent T-ALL and T-LBL. The sample size of this study is estimated according to the treatment period of 4 cycles.

Phase:

PHASE3

Details

Lead Sponsor:

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Treatments:

nelarabine