Clinical trial NCT06361329: Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: ETP-ALL
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 81
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: 1-year EFS
timeFrame: 1 year
Secondary outcomes:
measure: CR/CRi
timeFrame: At the end of Cycle 1 (up to 42 days)
measure: OS
timeFrame: through study completion, up to 3 years
measure: MRD
timeFrame: At the end of Cycle 1 (up to 42 days)
measure: Safety of induction therapy
timeFrame: At the end of Cycle 1 (up to 42 days)
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: