Actively Recruiting
Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl/VACh in Newly Diagnosed Acute Myeloid Leukemia
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-11-19
172
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Soochow University
Lead Sponsor
J
Jining Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This prospective, multi-center, randomized, controlled Phase II study is to compare the therapeutic efficacy and side effect of VACl (Venetoclax,Azacitidine,Cladribine) alternating with VACh (Venetoclax,Azacitidine,Chidamide), VACl, VACh and VA in newly diagnosed adult acute myeloid leukemia (AML) patients ineligible for intensive therapy or declining. Cladribine is a purine analogue widely used in hematologic malignancies. The monocytic leukemia stem cell is selective sensitivity to Cladribine. Chidamide, a newly designed selective histone deacetylase inhibitor, could down regulate myeloid cell leukaemia 1 (MCL1) expression in Venetoclax resistant AML cells. Chidamide or Cladribine have synergistic anti-leukemia effects with VA through their unique mechanisms, which can eradicate leukemia stem cells and prevent the occurrence of drug resistance.
CONDITIONS
Official Title
Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl/VACh in Newly Diagnosed Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously untreated AML confirmed by WHO criteria and ineligible for standard intensive chemotherapy due to age or comorbidities
- Age 18 years or older with at least one of the following: 60 years or older; under 60 but unsuitable for standard induction therapy; or refusal of conventional intensive chemotherapy
- Adequate liver function (bilirubin ≤ 2 mg/dL, AST and/or ALT ≤ 3 times upper limit of normal) unless due to leukemia infiltration
- Adequate kidney function (creatinine ≤ 1.5 times upper limit of normal)
- ECOG performance status of 2 or less
- Negative urine pregnancy test within 1 week for women of childbearing potential
- Ability to understand study requirements and provide signed informed consent
- Projected life expectancy of at least 12 weeks
You will not qualify if you...
- History of other malignancies except adequately treated in situ cervical or breast carcinoma, basal cell or localized squamous cell skin carcinoma, or previous malignancy treated with curative intent
- Diagnosis of acute promyelocytic leukemia or history of myeloproliferative neoplasms including myelofibrosis, essential thrombocythemia, polycythemia vera, or chronic myeloid leukemia with or without BCR-ABL1 translocation
- Active central nervous system involvement with AML
- White blood cell count greater than 25 x 10^9/L (hydroxyurea allowed to meet this criterion)
- Prior treatment with venetoclax, cladribine, hypomethylating agents, chidamide, CAR T-cell therapy, or experimental therapies for MDS or AML
- Malabsorption syndrome or conditions preventing oral drug administration
- Known HIV infection
- Use of strong or moderate CYP3A inducers within 7 days before study treatment
- Consumption of grapefruit, Seville oranges, or starfruit within 3 days before study treatment
- Cardiovascular disease classified as New York Heart Association Class 2 or higher
- Chronic respiratory disease requiring continuous oxygen
- Significant medical conditions including renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, or cardiovascular disease that may affect study participation
- Uncontrolled infections requiring therapy
- Known hepatitis B or C infection unless viral load is undetectable within 3 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
S
Sheng-Li Xue, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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