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

Zhejiang University

Status and phase

Enrolling

Phase 3

Conditions

ETP-ALL

Treatments

Drug: G-CSF

Drug: venetoclax

Drug: Cytarabine

Drug: Dexamethasone

Drug: Vindesine

Drug: cyclophosphamide

Drug: Daunorubicin

Drug: Homoharringtonine

Drug: L-ASP

Study type

Interventional

Funder types

Other

Identifiers

NCT06361329

20240030C

Details and patient eligibility

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.

Enrollment

81 estimated patients

Sex

All

Ages

14 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

81 participants in 2 patient groups

VHAG group

Experimental group

Description:

Venetoclax: 100mg on day 1, 200mg on day 2, and 400mg on days 3-14, if the blast cells in bone marrow were more than 5% on day 14, the patient continued to receive venetoclax 400mg until day 28. HHT:1.4 mg/m2,2mg maximum daily, intravenously daily from on d1-7 Cytarabine :10 mg/m2 subcutaneously every 12h on d1-14（d10-d14） G-CSF: 100ug/m2 daily on d1-14 if WBC count \<10\*10E9/L

Treatment: