Testing a Combined Drug Schedule for Older Adults With New Leukemia
Tests alternating VA and low-dose CHA in unfit adults newly diagnosed with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Alternating Regimen of VA and Low-dose CHA in the Treatment of Unfit Newly Diagnosed AML
Key facts
- Where
- Beijing, Hangzhou, Nanchang, Shenzhen, and Suzhou, ChinaSee the 5 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed acute myeloid leukemia (AML) who cannot or do not want to have intensive chemotherapy. It tests two drug regimens given in turn.
- Age
- 18 years or older. Adults aged 60 or older can join. Adults aged 18-59 can join only if intensive chemotherapy is not possible for them.
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed AML (WHO 2022 criteria) with no earlier treatment. The person cannot or does not want to have intensive chemotherapy (IC).
- Earlier treatment
- No earlier AML treatment. Only treatment to lower a very high white blood cell count (hydroxyurea, leukapheresis) and growth factor support are allowed.
- Biomarker or test result
- People with FLT3-ITD mutations cannot join.
Main reasons for not taking part
- AML that arose from chronic myeloid leukemia, myeloid sarcoma, or acute promyelocytic leukemia (APL)
- FLT3-ITD mutation
- Another active cancer within the last 2 years (some exceptions)
- Major surgery or cancer drug treatment within 28 days before starting
- Uncontrolled active infection
Read by machine on 12 November 2026.
Where in China
- Beijing Chao-Yang Hospital, Capital Medical UniversityBeijing, ChinaContact: Honghu ZhuTaking people
- Bone Marrow Transplantation Center, the First Affiliated Hospital, Zhejiang University School of MedicineHangzhou, ChinaContact: Jie SunTaking people
- The Second Affiliated Hospital of Nanchang UniversityNanchang, ChinaContact: Li YuTaking people
- Shenzhen university General HospitalShenzhen, ChinaContact: Lixin WangTaking people
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaContact: Suning ChenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- First Affiliated Hospital of Zhejiang University
- Trial code
- NCT07172204
- Record updated
- 4 February 2026
- Original description
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.Read full original descriptionShow less
The Efficacy and Safety of VA Alternating With Low-dose CHA in the Treatment of Newly Diagnosed Unfit AML: a Prospective, Multi-centers, Single Arm Phase II Study
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.
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: 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; 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; Prior AML-directed therapy except: cytoreduction for hyperleukocytosis per institutional guidelines (hydroxyurea, leukapheresis); supportive growth factors; 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; Psychiatric disorders or social circumstances compromising protocol compliance; Pregnancy/lactation or refusal of contraception: Negative serum β-hCG within 24h pre-C1D1; Diagnosis of: AML arising from chronic myeloid leukemia (CML); myeloid sarcoma; acute promyelocytic leukemia (APL) or presence of FLT3-ITD mutations.