Actively Recruiting
Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-02-17
81
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14 years or older and younger than 75 years
- 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 at least 3 months
- Able to take venetoclax by mouth
- No organ dysfunction that would restrict treatment
- Understand and sign the informed consent form
- Men and women of childbearing potential and their partners must use effective contraception during treatment and for 12 months after last dose
You will not qualify if you...
- Unable to take venetoclax by mouth
- Severe heart, lung, liver, kidney, or other organ dysfunction restricting participation
- Uncontrolled active systemic infection (viral, bacterial, or fungal)
- History of other cancers within 5 years except localized thyroid or in situ skin cancer
- Serum total bilirubin over 1.5 times normal (except leukemia infiltration)
- ALT, AST, or ALP over 5 times normal
- Serum creatinine over 1.5 times normal and creatinine clearance under 40 mL/min
- Left ventricular ejection fraction under 50%
- Known HIV infection
- Known central nervous system leukemia infiltration
- Gastrointestinal diseases affecting venetoclax absorption
- Unable to understand or follow the study protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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