Actively Recruiting
Alternating Regimen of VA and Low-dose CHA in the Treatment of Unfit Newly Diagnosed AML
Led by First Affiliated Hospital of Zhejiang University · Updated on 2026-02-04
25
Participants Needed
5
Research Sites
202 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Zhejiang University
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well VA alternating with low-dose CHA works in treating unfit patients with newly diagnosed acute myeloid leukemia (AML). This is a prospective, multi-centers, single arm phase II study aimed to overcome VEN resistance and achieve greater MRD negative rate, providing better control of treatment for unfit AML.
CONDITIONS
Official Title
Alternating Regimen of VA and Low-dose CHA in the Treatment of Unfit Newly Diagnosed AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the research and sign a written informed consent form
- Newly diagnosed with AML according to WHO 2022 criteria without prior treatment or unwilling to undergo intensive chemotherapy
- Age 60 years or older
- Age 18-59 years but ineligible for intensive chemotherapy with at least one of the following: ECOG performance status 2 or higher at screening, severe heart failure (requiring treatment or history of myocardial infarction with ejection fraction 50% or less), severe pulmonary dysfunction (DLCO 65% or less, FEV1 65% or less, dyspnea at rest, or oxygen dependence), severe renal insufficiency requiring dialysis, Child-Pugh B or C cirrhosis, or hepatic impairment with total bilirubin greater than 1.5 times the upper limit of normal
- No mental illness requiring inpatient psychiatric treatment
- No comorbidity that contraindicates intensive chemotherapy as judged by the physician
You will not qualify if you...
- Diagnosis of AML arising from chronic myeloid leukemia, myeloid sarcoma, acute promyelocytic leukemia, or presence of FLT3-ITD mutations
- Active malignancies within 2 years prior to treatment except adequately treated carcinoma in situ or basal cell carcinoma
- Major surgery or systemic anticancer therapy within 28 days before treatment start
- Known hypersensitivity to cladribine, homoharringtonine, cytarabine, venetoclax, azacitidine, or any excipients in the study drugs
- Gastrointestinal conditions impairing oral drug absorption such as dysphagia, short-gut syndrome, gastroparesis, or related disorders
- Uncontrolled active infection
- Controlled infection only if afebrile and hemodynamically stable for at least 72 hours pre-treatment, on non-interacting antimicrobial regimen, with viral load monitoring for chronic HBV/HCV carriers, or HIV-positive patients on HAART
- Pregnancy or lactation, or refusal to use contraception with negative serum beta-hCG within 24 hours before treatment
- Psychiatric disorders or social circumstances that compromise protocol compliance
- Prior AML-directed therapy except cytoreduction for high white blood cell count or supportive growth factors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
2
Shenzhen University General Hospital
Shenzhen, Guangdong, China
Actively Recruiting
3
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
4
the Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
5
Bone Marrow Transplantation Center, the First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
J
Jie Sun
CONTACT
Y
Yuanyuan Dr. Zhu, M.D, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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