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

Not Applicable

Recruiting

• Conditions: Adult T-cell Leukemia/Lymphoma
• Interventions: Drug: VEN (Venetoclax); Drug: Azacitidine (AZA); Drug: Chidamide; Drug: vindesine; Drug: Dexamethasone

• Registration Number: NCT07159620
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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) .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-26
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-05
• Last Update Submitted: 2025-09-05
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Primary Completion: 2028-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone	VEN (Venetoclax)	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)
Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone	Azacitidine (AZA)	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)
Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone	Chidamide	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)
Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone	vindesine	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)
Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone	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)

Primary Outcome Measures

Name	Time	Method
Composite Complete Remission Rate（CRc） after induction therapy	Time from the completion of induction and before consolidation therapy（up to 42 days）	Rates of complete remission (CR), and complete remission with incomplete hematologic recovery (CRi)

Secondary Outcome Measures

Name	Time	Method
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）	Percentage of participants who converted to MRD \< 10\^-4 by flow cytometry
Overall survival（OS）	2 years	Time from the date of enrollment to death from any cause or the last follow-up
duration of remission (DOR)	2 years	Time between the first remission and relapse
AE	Within 30 days after the last chemotherapy	Adverse events during the chemotherapy treatment.
Relapse-Free Survival(RFS)	2 years	The duration from the date of the first complete remisson to the occurrence of relapse, death from any cause, or the last follow-up.

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China