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RECRUITING

NCT07172204

PHASE2

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

Sponsor: First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

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 phase II study aimed to overcome VEN resistance and achieve greater MRD negative rate, providing better control of treatment for unfit AML.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-16

Completion Date

2029-07-31

Last Updated

2026-02-04

Healthy Volunteers

Conditions

Intensive Chemotherapy Unfit Newly Diagnosed Acute Myeloid Leukemia (AML)Age ≥60

Interventions

DRUG

Alternately treated with VA/low CHA regimen

1. Induction Phase (4 alternating cycles): Participants will receive 4 cycles of alternating therapy: * VA Cycle: * Venetoclax 400 mg PO daily on Days 1-28 * Azacitidine 75 mg/m² SC daily on Days 1-7 * Low-dose CHA Cycle: * Cladribine 5 mg/m² IV daily on Days 1-3 * Homoharringtonine 1 mg/m² IV daily on Days 1-5 * Cytarabine 20 mg SC every 12 hours on Days 1-10 Alternating sequence: VA → CHA → VA → CHA → VA → CHA → VA → CHA 2. Maintenance Phase (24 months): Following induction, participants will receive: * Venetoclax 400 mg PO daily on Days 1-28 * Azacitidine 75 mg/m² SC daily on Days 1-7 Repeated every 28 days for 24 cycles. We aimed to compare this clinical intervention with standard VA which is: * Venetoclax 400 mg PO daily on Days 1-28 * Azacitidine 75 mg/m² SC daily on Days 1-7 Repeated every 28 days for at least 24 cycles.

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;

Locations (5)

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Shenzhen University General Hospital

Shenzhen, Guangdong, China

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

the Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Bone Marrow Transplantation Center, the First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China