-Author name in bold denotes the presenting author
-Asterisk * with author name denotes a Non-ASH member
Clinically Relevant Abstract denotes an abstract that is clinically relevant.

PhD Trainee denotes that this is a recommended PHD Trainee Session.

Ticketed Session denotes that this is a ticketed session.

2898 Venetoclax Plus D-CAG (decitabine, cytarabine, aclarubicin, G-CSF) for Elderly or Unfit Patients with Newly Diagnosed Acute Myeloid Leukemia: A Multicenter, Prospective Study

Program: Oral and Poster Abstracts
Session: 617. Acute Myeloid Leukemias: Commercially Available Therapies: Poster II
Hematology Disease Topics & Pathways:
Research, Clinical trials, Clinical Research
Sunday, December 8, 2024, 6:00 PM-8:00 PM

Hongbing Ma1*, Yiwen Du1*, Jianjun Li1*, Jin Rao2*, Yong Guo1*, Yunfan Yang1*, Duanzhong Zhang3*, Jia Wang4*, Yi Liao5* and Yuping Gong6*

1West China Hospital, Sichuan University, Chengdu, China
2Department of Hematology, Affiliated Hospital of Chengdu University, Chengdu, Ch, Chengdu, CHN
3Department of Hematology, Dazhou Central Hospital, Dazhou, China, Dazhou, CHN
4Department of Hematology, The Second People's Hospital of Neijiang, Neijiang, Ch, Neijiang, CHN
5Department of Hematology, West China Hospital, Sichuan University, Chengdu, China
6West China Hospital, Sichuan University, Chengdu, CHN

Background:

Induction regimens with satisfactory remission rates are limited for patients with acute myeloid leukemia (AML) who are elderly or ineligible for intensive chemotherapy.

Objectives:

This study aims to evaluate the efficacy and safety of venetoclax plus decitabine, cytarabine, aclarubicin, and granulocyte colony-stimulating factor (VD-CAG) for newly diagnosed AML patients who are elderly or ineligible for intensive chemotherapy.

Design:

This is a single-arm, multicenter, prospective phase I/II study.

Methods:

The patients(n=40) received 1 cycle of the VD-CAG regimen for induction chemotherapy. The primary endpoint was composite complete remission (CRc) after 1 cycle of induction chemotherapy. The secondary endpoints were measurable residual disease (MRD) by flow cytometry and adverse events.

Results:

The median age of the patients was 64 (55-81) years, and 10 patients (25%) had secondary AML. Our results showed that 1 cycle of VD-CAG had a high overall response rate of 97.5% and CRc of 95%, and all 10 patients with secondary AML achieved CRc. Moreover, the patients who achieved CRc had deep remission, with MRD-negativity of 71.1% and 54.2% by flow cytometry and molecular assessment, respectively. In addition, blood cell recovery was quick, with a median time to absolute neutrophil count ≥ 1.0×109/L and platelet count ≥ 100×109/L at 19 days and 15.5 days, respectively.

Conclusions:

VD-CAG demonstrates high efficacy as an induction treatment for elderly or unfit patients with newly diagnosed AML, and it could be an alternative upfront therapy for this subpopulation, Trials with large-scale subjects are needed for further validation, especially for secondary AML.

Disclosures: No relevant conflicts of interest to declare.

*signifies non-member of ASH