Status:
RECRUITING
Alternating Regimen of VA and Low-dose CHA in the Treatment of Unfit Newly Diagnosed AML
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborating Sponsors:
AbbVie
Conditions:
Intensive Chemotherapy Unfit
Newly Diagnosed Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
This clinical study protocol investigates a novel treatment for newly diagnosed Acute Myeloid Leukemia (AML) patients ineligible to receive intensive chemotherapy (IC). Eligibility is defined as age ≥...
Eligibility Criteria
Inclusion
- Understand the research and sign a written informed consent form;
- Be newly diagnosed with AML according to WHO 2022 criteria without prior treatment;
- or unwilling to undergo IC. Ineligibility for IC is defined as meeting any of the following criteria:
- Age ≥ 60 years
- Age 18-59 years but ineligible for intensive chemotherapy (IC) , meet ≥1 of the following:
- Eastern Cooperative Oncology Group (ECOG) performance status ≥2 at screening;
- Severe heart failure (congestive heart failure requiring treatment or myocardial infarction history with ejection fraction ≤50%);
- Severe pulmonary dysfunction (DLCO ≤65%, FEV1 ≤65%, dyspnea at rest, or oxygen dependence);
- Severe renal insufficiency requiring dialysis;
- Child-Pugh B or C cirrhosis, or hepatic impairment with total bilirubin \>1.5×ULN;
- Mental illness requiring inpatient psychiatric treatment;
- Any comorbidity deemed by physician to contraindicate IC.
Exclusion
- Diagnosis of: AML arising from chronic myeloid leukemia (CML); myeloid sarcoma; acute promyelocytic leukemia (APL) or presence of FLT3-ITD mutations;
- Active malignancies (except adequately treated carcinoma in situ or basal cell carcinoma) within 2 years prior to Cycle 1 Day 1 (C1D1);
- Major surgery or systemic anticancer therapy within 28 days before C1D1;
- Known hypersensitivity to: Active pharmaceutical ingredients: cladribine, homoharringtonine, cytarabine, venetoclax, azacitidine; Any excipients in study drug formulations;
- GI conditions impairing oral drug absorption: Dysphagia; short-gut syndrome; gastroparesis or related disorders;
- Uncontrolled active infection;
- Controlled infection permitted if: Afebrile (\<38°C) and hemodynamically stable (SBP \>90 mmHg, HR \<100 bpm) for ≥72 hours pre-C1D1; on non-interacting antimicrobial regimen; active HBV/HCV infection (Chronic carriers require PI approval with viral load monitoring); HIV-positive patients receiving HAART;
- Pregnancy/lactation or refusal of contraception: Negative serum β-hCG within 24h pre-C1D1;
- Psychiatric disorders or social circumstances compromising protocol compliance;
- Prior AML-directed therapy except: cytoreduction for hyperleukocytosis per institutional guidelines (hydroxyurea, leukapheresis); supportive growth factors;
Key Trial Info
Start Date :
September 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2029
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07172204
Start Date
September 16 2025
End Date
July 31 2029
Last Update
November 28 2025
Active Locations (5)
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1
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
2
Shenzhen University General Hospital
Shenzhen, Guangdong, China
3
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
4
the Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China