NCT06361329

Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL

A Multicenter, Prospective, Randomized Controlled Clinical Study Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in the Treatment of Adult Newly Diagnosed Early Precursor T-cell Acute Lymphoblastic Leukemia (ETP-ALL)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

ETP-ALL is a subtype of T-cell acute lymphoblastic leukemia (T-ALL) with poor outcomes and prognosis. Effective induction therapy is crucial in improving the treatment effect. Based on our laboratory research and clinical practice, the venetoclax plus HAG regimen shows promising efficacy in treating ETP-ALL. Therefore, we plan to conduct a prospective, multicenter Phase III clinical study to evaluate the efficacy of the venetoclax plus HAG regimen in treating newly diagnosed ETP-ALL patients.

Conditions

• ETP-ALL

Interventions

Type	Name	Description
DRUG	Homoharringtonine	Intravenous infusion
DRUG	venetoclax	Orally by mouth
DRUG	Cytarabine	subcutaneous injection or Intravenous infusion
DRUG	G-CSF	subcutaneous injection
DRUG	Vindesine	Intravenous infusion
DRUG	Daunorubicin	Intravenous infusion
DRUG	cyclophosphamide	Intravenous infusion
DRUG	Dexamethasone	Intravenous infusion or orally
DRUG	L-ASP	subcutaneous injection

Timeline

• Start date: 2024-04-03
• Primary completion: 2026-03-31
• Completion: 2027-03-31
• First posted: 2024-04-11
• Last updated: 2025-02-17

Locations

1 site across 1 country: China