Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Homoharringtonine, venetoclax, Cytarabine, G-CSF.
- Who it may be relevant to
- Registry conditions: ETP-ALL. Basic parameters: 14 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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.
Interventions
- 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
Primary outcome measures
- 1-year EFS [Time frame: 1 year]
Secondary outcome measures (4)
- CR/CRi [Time frame: At the end of Cycle 1 (up to 42 days)]
- OS [Time frame: through study completion, up to 3 years]
- MRD [Time frame: At the end of Cycle 1 (up to 42 days)]
- Safety of induction therapy [Time frame: At the end of Cycle 1 (up to 42 days)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou
Identifiers
NCT: NCT06361329 · 20240030C