Actively Recruiting
Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl/VACh in Newly Diagnosed Adult Acute Myeloid Leukemia Patients Ineligible for Intensive Therapy or Declining: A Prospective, Multi-center, Randomized, Controlled Phase II Study
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-11-19
172
Participants Needed
1
Research Sites
52 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 research evaluates treatments for adults newly diagnosed with acute myeloid leukemia (AML) who cannot undergo or decline intensive therapy. It compares the effects and side effects of four drug combinations involving Venetoclax, Azacitidine, Cladribine, and Chidamide. The study focuses on improving response rates and overcoming drug resistance by targeting leukemia stem cells, addressing challenges of current therapies in this patient group. Participants are randomly assigned to one of four treatment groups: VA (Venetoclax and Azacitidine), VACl (adding Cladribine), VACh (adding Chidamide), or alternating VACl and VACh. Each treatment involves cycles with specific dosing schedules, including subcutaneous and oral medications, with bone marrow assessments after two cycles. Patients achieving remission may continue post-remission therapy until disease progression or receive other treatments if eligible. Throughout the study, patients undergo bone marrow tests, evaluations of remission status, and monitoring for side effects. Researchers will measure outcomes like event-free survival and relapse rates over one year. The study includes regular assessments of blood counts, adverse reactions, and overall survival. Participation lasts through treatment cycles and follow-up until disease progression or treatment change.
CONDITIONS
Brief 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...
- Adults aged 18 years or older with newly diagnosed acute myeloid leukemia (AML) confirmed by WHO criteria
- Ineligible for standard intensive chemotherapy due to age, comorbidities, or patient refusal
- Adequate liver function (bilirubin ≤ 2 mg/dL; AST and/or ALT ≤ 3 times upper limit of normal unless due to leukemia)
- Adequate kidney function (creatinine ≤ 1.5 times upper limit of normal)
- ECOG performance status of 2 or less
- Negative pregnancy test within 1 week before enrollment for women of childbearing potential
- Ability to understand study requirements and provide 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 skin carcinoma, or previous malignancy treated with curative intent
- Diagnosis of acute promyelocytic leukemia or myeloproliferative neoplasms including myelofibrosis, essential thrombocythemia, polycythemia vera, or CML with or without BCR-ABL1
- Known 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 medication
- Known HIV positive status
- 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 or significant other medical conditions that could interfere with participation
- Active uncontrolled systemic infection
- Known hepatitis B or C infection unless viral load is undetectable within 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 cycles of 21 to 28 days each
Participants receive treatment cycles with one of four drug regimens: VA, VACl, VACh, or alternating VACl/VACh. Each cycle lasts 21 to 28 days, and participants receive 2 cycles. Bone marrow assessments occur on days 21 to 28 of each cycle to evaluate response. Those achieving remission proceed to post-remission therapy while others withdraw from the trial.
2 treatment cycles with bone marrow assessments at the end of each cycle
Duration - Until disease progression or recurrence
Participants who achieve remission and are ineligible for intensive chemotherapy or decline it continue with the assigned regimen until disease progression or recurrence. Participants eligible for intensive chemotherapy may receive other treatments and withdraw if disease progresses.
Ongoing visits during treatment continuation
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.
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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