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Alternating Regimen of VA and Low-dose CHA in the Treatment of Unfit Newly Diagnosed AML

RecruitingPhase 2Ages 18 Years - anyAllFirst Affiliated Hospital of Zhejiang University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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;
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What it tests

  • Alternately treated with VA/low CHA regimen
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Where

5 sites
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
Shenzhen University General Hospital
Shenzhen, China
the First Affiliated Hospital of Soochow University
Suzhou, China
the Second Affiliated Hospital of Nanchang University
Nanchang, China
Bone Marrow Transplantation Center, the First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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