Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients

NCT07159620 | Recruiting Phase 2

• 1 other identifier: 2025662
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

ETP-ALL like patients have poor outcomes and prognosis, and the optimal therapeutic approaches are poorly characterized. The goal of this clinical trial is to evaluate the efficacy and safety of the venetoclax combined with azacitidine, chidamide, vindesine, and dexamethasone regimen in newly diagnosed ETP-ALL like patinets (including ETP-ALL, near ETP-ALL and T-ALL with myeloid mutations) .

Conditions

Adult T-cell Leukemia/Lymphoma

Outcome Measures

Primary Outcomes (1)

• Composite Complete Remission Rate（CRc） after induction therapy

  Rates of complete remission (CR), and complete remission with incomplete hematologic recovery (CRi)

  Time from the completion of induction and before consolidation therapy（up to 42 days）

Secondary Outcomes (5)

• Overall survival（OS）

  2 years

• Relapse-Free Survival(RFS)

  2 years

• duration of remission (DOR)

  2 years

• AE

  Within 30 days after the last chemotherapy

• MRD

  At the end of induction（up to 42 days）, 1 cycle of consolidation（up to 42 days）, 2 cycle of consolidation （up to 42 days）and the end of consolidation（up to 42 days）

Study Arms (1)

Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone

EXPERIMENTAL

Induction Therapy Phase: VACVP induction:Venetoclax: 100mg, d1, 200mg, d2, 400mg, d3-d21, orally. Azacitidine,75mg/m²/day, d1-d7, subcutaneously. Chidamide,10mg, d1-d7, orally. Vindesine, 4mg, d1, intravenous infusion. Dexamethasone,9mg/m²/day, d1-d14; reduced by half on d15-d17; further reduced by half on d18-d21, intravenous infusion or orally. Consolidation therapy: 1. alternate use of HD-MTX-Ara C and VACVP 2. allogeneic hematopoietic stem cell transplantation (HSCT)

Drug: VEN (Venetoclax); Drug: Azacitidine (AZA); Drug: Chidamide; Drug: vindesine; Drug: Dexamethasone

Interventions

VEN (Venetoclax) DRUG

Orally

Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone

Azacitidine (AZA) DRUG

Subcutaneous injection

Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone

Chidamide DRUG

Orally

Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone

vindesine DRUG

intravenous infusion

Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone

Dexamethasone DRUG

intravenous infusion or orally

Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone

Eligibility Criteria

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

You may qualify if:

• Age: \>14 to 65 years (inclusive).
• Diagnosis: Patients diagnosed with ETP-ALL like disease meeting the following flow cytometry immunophenotypic criteria:
• ETP-ALL: CD7+, CD1a-, CD8-, CD5 positivity rate ≤75%, and positive for at least one myeloid/stem cell antigen marker (including but not limited to CD34, CD117, HLA-DR, CD13, CD33, CD11b, or CD65); MPO negative.
• Near-ETP-ALL: CD7+, CD1a-, CD8-, CD5 positivity rate \>75%, AND positive for at least one myeloid/stem cell antigen marker (including but not limited to CD34, CD117, HLA-DR, CD13, CD33, CD11b, or CD65); MPO negative.
• T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1.
• Newly diagnosed patients who have not received any prior induction therapy before enrollment (excluding hydroxyurea, dexamethasone, low-dose cytarabine, venetoclax with a cumulative dose \<0.5g, and leukapheresis).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
• Expected survival \>6 months.
• Demonstrated capacity to understand the study and willingness to provide informed consent.

You may not qualify if:

• Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential
• Presence of uncontrolled active infection (including bacterial, fungal, or viral infections); concurrent active HBV, HCV, or HIV infection.
• Severe Organ Dysfunction:
• Cardiac Insufficiency: Left ventricular ejection fraction (LVEF) ≤40%, OR history of congestive heart failure, unstable coronary artery disease, or severe arrhythmia.
• Respiratory Failure: Partial pressure of arterial oxygen (PaO₂) ≤60 mmHg. Hepatic Impairment: Total bilirubin ≥2 times the upper limit of normal (ULN), OR alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times ULN.
• Renal Impairment: Serum creatinine ≥2 mg/dL, OR creatinine clearance ≤30 mL/min/1.73m².
• Hypersensitivity: History of hypersensitivity to any of the study drugs or compounds of similar chemical structure.
• Presence of central nervous system (CNS) leukemia.
• Any other condition deemed by the investigator to make the subject unsuitable for participation in this trial.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

venetoclax; Azacitidine; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Vindesine; Dexamethasone

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Yang Xu

CONTACT

86+051267781850; xuyang1020@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

CN (1)