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1517 Venetoclax Combined with Homoharringtonine,Cytarabine and Aclacinomycin (HAAV) As Induction Therapy in Newly Diagnosed Young Adult Acute Myeloid Leukemia

Program: Oral and Poster Abstracts
Session: 615. Acute Myeloid Leukemias: Commercially Available Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster I
Hematology Disease Topics & Pathways:
Combination therapy, Therapies
Saturday, December 9, 2023, 5:30 PM-7:30 PM

Zepin Zhou, PhD1*, Xingli Zhao2*, Xiaohui Suo3*, Guanchen Bai4*, Zeyan Shi5*, Yunya Luo6*, Yaxian Tan1*, Xinxiao Lu7*, Linyu Yuan7*, Congcong Zhang3*, Yinling Li3*, Sifeng Gao4*, Jilei Zhang4*, Heng Li6*, Weihua Zhao, MD, PhD5*, Hongling Peng6*, Pengxiang Guo8*, Yingchang Mi, MD9,10 and Kaiqi Liu10,11*

1Department of Hematology, The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China, Kunming, China
2Tianjin People's Hospital, Tianjin, China
3Department of Hematology, Handan Central Hospital, Handan, Hebei, China, 056000,, Handan, China
4Department of Hematology, The Affiliated Tai'an City Central Hospital of Qingdao University, Taian, Shandong, China, 271000., Taian, China
5Department of Hematology, The First Affiliated Hospital of Guangxi Medical University, Nanning, China
6Department of Hematology, The Second Xiangya Hospital, Central South University, Changsha, 410011, Hunan, People's Republic of China, Changsha, China
7Department of Hematology, Oncology Center, Tianjin People's Hospital, No. 190 jieyuan Road, Hongqiao District, Tianjin 300121, P R China., Tianjin, China
8Department of Hematology, Guizhou Provincial People’s Hospital, Guiyang, Guizhou, China, Guiyang, China
9State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences &Peking Union Medical College, Tianjin, China
10Tianjin Institutes of Health Science, Tianjin, China
11National Clinical Research Center for Blood Diseases, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences &Peking Union Medical College, Tianjin, China


The remission rate of acute myeloid leukemia (AML) patients using traditional induction chemotherapy is approximately 60-70%. Venetoclax (Ven), a b-cell lymphoma 2 (BCL-2) inhibitor, in combination with chemotherapy or hypomethylating agents, has shown a significant increase in remission rates and improvement in patient survival for elderly or unfit for intensive chemotherapy newly diagnosed AML patients. The HAA regimen (consisting of Homoharringtonine, Cytarabine and Aclacinomycin), a specific traditional induction therapy for acute myeloid leukemia in China. The HAA regimen achieved complete remission rates about 70% as an induction regimen for newly diagnosed AML. Whether the combination of Ven with HAA regimen as an induction treatment can further enhance the complete remission rate in newly diagnosed adult AML patients requires investigation through well-designed clinical trials.


To evaluate the efficacy and safety of HAA combined with Ven as induction regimen (HAAV) in young adult patients with newly diagnosed AML.

Design, setting and participants:

Single-arm, prospective clinical trial conducted at 8 hospitals in China. Eligible patients (16-60 years old) with newly diagnosed AML (exclude acute promyelocytic leukemia) were enrolled. The trial was registered on ClinicalTrials.gov (NCT05893472) and continues to accrue patients.

Induction regimen:

The induction regimen consisted of Homoharringtonine (2.5mg/㎡/d,d3-7 ), cytarabine (100mg/㎡/d by continuous intravenous infusion daily on d3-7) and Aclacinomycin (20mg/d, d3-7) combined with venetoclax (100mg d1, 200mg d2, 400mg d3-8).

Main outcomes and measures:

The primary endpoint was the overall response rate (ORR) after once cycle of HAAV regimen, which included complete remission (CR), complete remission with incomplete count recovery (CRi), morphologic leukemia-free state (MLFS) and partial remission (PR). Secondary endpoints included minimal residual disease (MRD), overall survival (OS), event-free survival (EFS) and adverse events.


Untill June 30, 2023, 40 patients were enrolled. The median age is 43 years (range, 18-60), with 60% (24/40) was male. According to the European Leukemia Network prognostic group (2022), 14 (35.0%), 14 (35.0%), and 12 (30.0%) patients were considered to belong to the favorable, intermediate, and adverse groups, respectively. Further details of the patients' characteristics are provided in Table 1.

The ORR (CR+PR) was 97.5% (39/40 patients) after one cycle of the induction regimen with the CR rate was 95.0% (38/40). According to the ELN prognostic group (2022), the CR was 100% in favorable-risk patients (14/14), 100% in intermediate-risk patients (14/14), and 83.3% in adverse-risk patients (10/12). For patients who achieved CR, MRD negative rate was 88.9% (32/36) by flow cytometry. During the induction treatment, all patients experienced ≥Grade 3 hematological toxicity, the remaining common adverse reactions were infections and fever. None of patients died during the induction therapy. In patients who achieved response, the median time to recovery of the white blood count (WBC) to ≥1.0 × 109/L and the platelet count to ≥20 × 109/L after induction therapy was 13 (range: 10–52) and 13 days (range: 2–33), respectively. (Table 1)


Ven combined with HAA (HAAV) is a highly effective and safe induction therapy for young adult patients with de novo AML. To the best of our knowledge, this is the first report about Ven combined with HAA.

Disclosures: No relevant conflicts of interest to declare.

*signifies non-member of ASH