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NCT Number: NCT06361329

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

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.

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Key information

Conditions

Age range

14 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location status: Recruiting

Location contact

Jie Jin, PhD&MD

CONTACT

[email protected]

13705716779

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Homoharringtonine

Drug

Intravenous infusion

Venetoclax

Drug

Orally by mouth

Cytarabine

Drug

subcutaneous injection or Intravenous infusion

G-CSF

Drug

subcutaneous injection

Vindesine

Drug

Intravenous infusion

Daunorubicin

Drug

Intravenous infusion

Cyclophosphamide

Drug

Intravenous infusion

Dexamethasone

Drug

Intravenous infusion or orally

L-ASP

Drug

subcutaneous injection

Primary outcomes

  1. 1-year EFS

    Time frame: 1 year

    1-year event free survival rate

Secondary outcomes

  1. CR/CRi

    Time frame: At the end of Cycle 1 (up to 42 days)

    Complete remission/complete remission with incomplete count recovery

  2. OS

    Time frame: through study completion, up to 3 years

    Overall survival

  3. MRD

    Time frame: At the end of Cycle 1 (up to 42 days)

    Percentage of participants who converted to MRD < 10^-3 after the first cycle of treatment.

  4. Safety of induction therapy

    Time frame: At the end of Cycle 1 (up to 42 days)

    Adverse events

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 11, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.