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

NCT ID: NCT07159620

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2030-09-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone

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)

Group Type: EXPERIMENTAL

VEN (Venetoclax)

Intervention Type: DRUG

Orally

Azacitidine (AZA)

Intervention Type: DRUG

Subcutaneous injection

Chidamide

Intervention Type: DRUG

Orally

vindesine

Intervention Type: DRUG

intravenous infusion

Dexamethasone

Intervention Type: DRUG

intravenous infusion or orally

Interventions

VEN (Venetoclax)

Orally

Intervention Type: DRUG

Azacitidine (AZA)

Subcutaneous injection

Intervention Type: DRUG

Chidamide

Orally

Intervention Type: DRUG

vindesine

intravenous infusion

Intervention Type: DRUG

Dexamethasone

intravenous infusion or orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age: >14 to 65 years (inclusive).

2. 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.

3. 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).

4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.

5. Expected survival >6 months.

6. Demonstrated capacity to understand the study and willingness to provide informed consent.

Exclusion Criteria

1. Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential

2. Presence of uncontrolled active infection (including bacterial, fungal, or viral infections); concurrent active HBV, HCV, or HIV infection.

3. 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.

4. Presence of central nervous system (CNS) leukemia.

5. Any other condition deemed by the investigator to make the subject unsuitable for participation in this trial.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang Xu

Role: CONTACT

xuyang1020@126.com

86+051267781850

Facility Contacts

Yang Xu

Role: primary

xuyang1020@126.com

86+051267972685

Other Identifiers

2025662

Identifier Type: -

Identifier Source: org_study_id