🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06361329
Recruiting Phase 3

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

NCT06361329 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital of Zhejiang University
Phase
Phase 3
Started
2024-04-03
Last updated
2025-02-17

Condition(s) studied

ETP-ALL

Investigational drug(s) / intervention(s)

Homoharringtonine →venetoclax →Cytarabine →G-CSF →Vindesine →Daunorubicin →cyclophosphamide →Dexamethasone →L-ASP

Homoharringtonine: Intravenous infusion

venetoclax: Orally by mouth

Cytarabine: subcutaneous injection or Intravenous infusion

G-CSF: subcutaneous injection

Vindesine: Intravenous infusion

Daunorubicin: Intravenous infusion

cyclophosphamide: Intravenous infusion

Dexamethasone: Intravenous infusion or orally

L-ASP: subcutaneous injection

Study 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.

Eligibility

Sex
ALL
Min age
14 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Age ≥14 and \<75 years old. * Diagnosed with ETP-ALL (including near-ETP ALL) before enrollment. * Newly diagnosed patients. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Expected survival of ≥3 months. * Able to undergo oral treatment with venetoclax. * No organ dysfunction that would restrict the treatment administered * Understanding of the study and signing of the informed consent form. * Men, women of childbearing potential (postmenopausal women must have been amenorrheic for at least 12 months to be considered infertile), and their partners must voluntarily use effective contraception methods as deemed appropriate by the investigator during the treatment period and for at least 12 months after the last dose of the study drug. Exclusion Criteria: * Patients who are unable to take venetoclax by mouth; * Patients with severe heart, lung, liver, kidney, or other organ dysfunction that may restrict their participation in this trial due to diseases; * Evidence of other clinically significant uncontrolled condition(s) such as uncontrolled and/or active systemic infection (viral, bacterial or fungal) * A history of other malignant tumors within the past 5 years, excluding localized thyroid cancer and in situ skin cancer; * Serum total bilirubin \>1.5 ULN (upper limit of normal) (excluding leukemia infiltration); ALT or AST or ALP \>5 ULN; serum creatinine \>1.5 ULN and creatinine clearance rate \<40 mL/min; LVEF \<50%; * Known HIV infection; * Known central nervous system leukemia infiltration; * Gastrointestinal diseases known to affect venetoclax absorption as judged by the investigator; * Inability to understand or comply with the study protocol.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou Zhejiang Recruiting

On this site

📄 Venclexta (venetoclax) drug profile →

More First Affiliated Hospital of Zhejiang University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06361329 on ClinicalTrials.gov ↗ ← All trials in China