NCT06434467

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

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 Children and Adults

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 83 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 1 Year – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• T-lymphoblastic Leukemia
• T-lymphoblastic Lymphoma

Interventions

Type	Name	Description
DRUG	Nelarabine injection	Nelarabine is a prodrug of the nucleotide metabolism inhibitor deoxyguanosine analogue 9-β-arabinoguanine (ARA-G). Nelarabine undergoes catalytic transformation by adenosine deaminase (ADA), resulting in the removal of its methoxy group and conversion into ARA-G, Subsequently, ARA-G undergoes sequential monophosphorylation by deoxyguanosine kinase and deoxycytosine nucleoside kinase, yielding the active compound 5'-Guanosine triphosphate (GTP), ARA-GTP. This active compound accumulates within leukemic blast cells and binds to deoxyribonucleic acid (DNA), effectively inhibiting DNA synthesis and ultimately leading to cell death.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-12-01
• Completion: 2026-05-01
• First posted: 2024-05-30
• Last updated: 2024-05-30

Locations

30 sites across 1 country: China