Clinical Study of Selinexor-Based Chemotherapy With Minimal or No Cytotoxic Agents in Treatment-Naïve AML Patients Unsuitable for Intensive Therapy: Focusing on Rapid Reduction of Blast Cells

This study aims to evaluate the efficacy and safety of selinexor-based chemotherapy-sparing regimens (including chemotherapy-free or dose-reduced approaches) in optimizing therapeutic strategies for treatment-naïve acute myeloid leukemia patients deemed unfit for intensive induction therapy. The investigation will focus on dynamic blast clearance patterns and early toxicity profiles to inform timely treatment adaptation during the critical induction window.

Study Overview

• Status: Not yet recruiting
• Conditions: AML (Acute Myeloid Leukemia)
• Intervention / Treatment: Drug: the XAB regimen

• Study Type: Interventional
• Enrollment (Estimated): 71
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andie Fu; Phone Number: 15926614832; Email: andie_fu@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
      • Contact: Andie Fu; Phone Number: 15926614832; Email: andie_fu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Newly diagnosed acute myeloid leukemia (AML) patients Ineligible or unwilling to receive intensive chemotherapy .①Patients deemed ineligible for intensive chemotherapy must meet the following criteria: Age 18 to 74 years with at least one of the following comorbidities; Eastern Cooperative Oncology Group (ECOG) performance status ≥3; Cardiac history requiring treatment for congestive heart failure; Left ventricular ejection fraction ≤50%; Chronic stable angina; Diffusing capacity of the lungs for carbon monoxide (DLCO) ≤65% or forced expiratory volume in 1 second (FEV1) ≤65%; Creatinine clearance ≥30 mL/min to <45 mL/min (Cockcroft-Gault formula); Moderate hepatic impairment: total bilirubin >1.5 to ≤3.0 × upper limit of normal (ULN); ②Other investigator-assessed comorbidities that preclude safe administration of intensive chemotherapy.
2. Hepatic function must meet the following criteria: Aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤3.0 × ULN; Total bilirubin ≤3.0 × ULN. (unless deemed attributable to leukemic organ involvement)
3. Renal function must meet the following criterion: Creatinine clearance ≥30 mL/min calculated using the Cockcroft-Gault formula.
4. No history of drug allergies within the protocol.
5. Participants with plans for pregnancy must agree to use contraception before enrollment in the study and for six months after the study ends. If a participant becomes pregnant or suspects pregnancy, she must immediately notify the investigator.
6. The participant understands and signs the informed consent form.

Exclusion Criteria:

1. A definitive diagnosis of Acute Promyelocytic Leukemia (APL).
2. Age <18 years or ≥75 years.
3. The participant has previously received any treatment for acute myeloid leukemia (AML), except for hydroxyurea.
4. Uncontrolled active infections (including bacterial, fungal, or viral infections) that are clinically significant and refractory to medical therapy.
5. Currently participating in another clinical study or planning to initiate treatment in this study within less than 4 weeks after the completion of therapy in a prior clinical study.
6. Patients who have other malignancies that require treatment.
7. A history of allergy to the study drugs.
8. Female participants who are pregnant or breastfeeding.
9. Human immunodeficiency virus (HIV) infection or syphilis infection.
10. Active hepatitis that remains uncontrolled despite active antiviral therapy (positive for hepatitis B virus deoxyribonucleic acid [HBV DNA] or hepatitis C virus ribonucleic acid [HCV RNA]).
11. Patients with persistent positivity for Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 (excluding those who have transitioned from positive to negative).
12. Conditions that the investigator considers may increase the risk to participants or interfere with the study results.
13. Other conditions that the investigator deems the participant unsuitable for enrollment in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; selinexor (X), azacitidine (A), and venetoclax (B) - the XAB regimen	Drug: the XAB regimen; the XAB regimen: a chemotherapy-free or low-dose chemotherapy regimen containing selinexor (X), azacitidine (A), and venetoclax (B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	1，3，6，12，18，24 months after treatment

Collaborators and Investigators

• Sponsor: Donghua Zhang

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2025
• Primary Completion (Estimated): October 20, 2027
• Study Completion (Estimated): October 20, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute
• Other Study ID Numbers: DHZ1962-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No