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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Chao-Yang Hospital, Capital Medical University
RECRUITING
Beijing
Bone Marrow Transplantation Center, the First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
the Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Shenzhen University General Hospital
RECRUITING
Shenzhen
the First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Jie Sun
jsun1492@zju.edu.cn
+8615305714109
Backup
Yuanyuan Dr. Zhu, M.D, Ph.D
zhuyyzju@zju.edu.cn
86-13906514060
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 25
Treatments
Experimental: VA alternating with low-CHA
single treatment arm
Related Therapeutic Areas
Sponsors
Collaborators: AbbVie
Leads: First Affiliated Hospital of Zhejiang University

This content was sourced from clinicaltrials.gov