Comparing a new treatment with traditional chemotherapy for a type of leukemia

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)

This study is testing a new treatment for young and middle-aged people with a tough type of leukemia to see if it works better than standard chemotherapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 81 (estimated)
• Ages: 14 Years to 75 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06361329 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy of a new treatment regimen combining venetoclax and homoharringtonine (HAG) for patients newly diagnosed with ETP-ALL, a subtype of T-cell acute lymphoblastic leukemia known for its poor prognosis. The study is a Phase III, multicenter trial that will compare this new approach against traditional chemotherapy regimens to determine which is more effective in improving patient outcomes. Eligible participants will be those aged 14 to 75 who meet specific health criteria and can tolerate oral medication. The trial seeks to provide a more effective induction therapy for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 14 to 75 who have been newly diagnosed with ETP-ALL and meet the study's health criteria.

Not a fit: Patients with severe organ dysfunction or those unable to take venetoclax orally may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with ETP-ALL.

How similar studies have performed: While this approach is promising, it is not clear if similar studies have shown success, as this specific combination is being evaluated in a Phase III setting.

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.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Conditions ETP-ALL