Alternating Regimen of VA and Low-dose CHA in the Treatment of Unfit Newly Diagnosed AML
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Zhejiang University
About this trial
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.
Eligibility criteria
Qualifiers
Understand the research and sign a written informed consent form;
Be newly diagnosed with AML according to WHO 2022 criteria without prior treatment;
Age ≥ 60 years
Eastern Cooperative Oncology Group (ECOG) performance status ≥2 at screening;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Alternately treated with VA/low CHA regimen
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
5Beijing Chao-Yang Hospital, Capital Medical University BeijingBeijing Municipality, China
Shenzhen University General Hospital ShenzhenGuangdong, China
the First Affiliated Hospital of Soochow University SuzhouJiangsu, China
the Second Affiliated Hospital of Nanchang University NanchangJiangxi, China
Sponsors and collaborators
First Affiliated Hospital of Zhejiang University
Lead sponsor
AbbVie
Collaborator
Source ClinicalTrials.gov