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

NCT06361329 | Recruiting Phase 3

• 1 other identifier: 20240030C
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

ETP-ALL

Outcome Measures

Primary Outcomes (1)

• 1-year EFS

  1-year event free survival rate

  1 year

Secondary Outcomes (4)

• CR/CRi

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

• OS

  through study completion, up to 3 years

• MRD

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

• Safety of induction therapy

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

Study Arms (2)

VHAG group

EXPERIMENTAL

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

Drug: Homoharringtonine; Drug: venetoclax; Drug: Cytarabine; Drug: G-CSF

Traditional Chemotherapy Regimen group

ACTIVE COMPARATOR

* VDCLP regimen * VD(/I) CP regimen * Hyper CVAD-A regimen * VDLP regimen

Drug: Cytarabine; Drug: Vindesine; Drug: Daunorubicin; Drug: cyclophosphamide; Drug: Dexamethasone; Drug: L-ASP

Interventions

Homoharringtonine DRUG

Intravenous infusion

VHAG group

venetoclax DRUG

Orally by mouth

VHAG group

Cytarabine DRUG

subcutaneous injection or Intravenous infusion

Traditional Chemotherapy Regimen group; VHAG group

G-CSF DRUG

subcutaneous injection

VHAG group

Vindesine DRUG

Intravenous infusion

Traditional Chemotherapy Regimen group

Daunorubicin DRUG

Intravenous infusion

Traditional Chemotherapy Regimen group

cyclophosphamide DRUG

Intravenous infusion

Traditional Chemotherapy Regimen group

Dexamethasone DRUG

Intravenous infusion or orally

Traditional Chemotherapy Regimen group

L-ASP DRUG

subcutaneous injection

Traditional Chemotherapy Regimen group

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Interventions

Homoharringtonine; venetoclax; Cytarabine; Granulocyte Colony-Stimulating Factor; Vindesine; Daunorubicin; Cyclophosphamide; Dexamethasone

Intervention Hierarchy (Ancestors)

Harringtonines; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indoles; Indolizidines; Indolizines; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 11, 2024
• Study Start: April 3, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 17, 2025

Record last verified: 2024-03

Locations

CN (1)