RecruitingPhase 3NCT06361329

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

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)


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

81 participants

Start Date

Apr 3, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 14 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing a new treatment combination called VHAG (venetoclax, homoharringtonine, cytarabine, and G-CSF) against standard chemotherapy regimens for a rare and aggressive type of leukemia called ETP-ALL (Early T-cell Precursor Acute Lymphoblastic Leukemia). ETP-ALL is often resistant to standard treatment, and this trial tests if this new combination works better. **You may be eligible if...** - You are 14–74 years old - You have been newly diagnosed with ETP-ALL - Your overall health allows you to participate (ECOG 0–2) - Your estimated survival is at least 3 months - You are able to take venetoclax (an oral medication) - You are willing to use effective contraception during and after treatment **You may NOT be eligible if...** - You have had previous treatment for this leukemia - You cannot swallow or absorb oral medications - You have serious heart, lung, liver, or kidney problems - You have another active cancer (other than early-stage thyroid or skin cancer) - You have an uncontrolled active infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHomoharringtonine

Intravenous infusion

DRUGvenetoclax

Orally by mouth

DRUGCytarabine

subcutaneous injection or Intravenous infusion

DRUGG-CSF

subcutaneous injection

DRUGVindesine

Intravenous infusion

DRUGDaunorubicin

Intravenous infusion

DRUGcyclophosphamide

Intravenous infusion

DRUGDexamethasone

Intravenous infusion or orally

DRUGL-ASP

subcutaneous injection


Locations(1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT06361329