Adult T-cell Leukemia/LymphomaPhase 2NCT07159620
Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients
A Phase 2 study testing VEN (Venetoclax), Azacitidine (AZA) and Chidamide in people with Adult T-cell Leukemia/Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Adult T-cell Leukemia/Lymphoma
- What is being tested?
- VEN (Venetoclax), Azacitidine (AZA) and Chidamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Sep 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: >14 to 75 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Yang Xu, 86+051267972685, xuyang1020@126.com
About this study
Official title: A Prospective Single-Arm Clinical Study of Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients
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
- Being tested
- VEN (Venetoclax), Azacitidine (AZA), Chidamide, vindesine, Dexamethasone
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEN (Venetoclax)Drug
Orally
Azacitidine (AZA)Drug
Subcutaneous injection
ChidamideDrug
Orally
vindesineDrug
intravenous infusion
DexamethasoneDrug
intravenous infusion or orally
| Study group | Role | What they receive |
|---|---|---|
| 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(aged 14-65, inclusive of 65); alternate use of reduced-dose MTX-Ara C and VACVP(aged 65-75, inclusive of 75);
2. allogeneic hematopoietic stem cell transplantation (HSCT). Receives: Drug: VEN (Venetoclax); Drug: Azacitidine (AZA); Drug: Chidamide; Drug: vindesine; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Complete Remission Rate（CRc） after induction therapy
Rates of complete remission (CR), and complete remission with incomplete hematologic recovery (CRi)
Measured: Time from the completion of induction and before consolidation therapy（up to 42 days）
Secondary outcomes (5)
Overall survival（OS）
Time from the date of enrollment to death from any cause or the last follow-up
Measured: 2 years
Relapse-Free Survival(RFS)
The duration from the date of the first complete remisson to the occurrence of relapse, death from any cause, or the last follow-up.
Measured: 2 years
duration of remission (DOR)
Time between the first remission and relapse
Measured: 2 years
AE
Adverse events during the chemotherapy treatment.
Measured: Within 30 days after the last chemotherapy
MRD
Percentage of participants who converted to MRD < 10^-4 by flow cytometry
Measured: 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）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult T-cell Leukemia/LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159620
- Sponsor's protocol ID
- 2025662
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided