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

NCT ID: NCT07236931

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-20
• Study Completion Date: 2028-10-20

Brief Summary

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.

Conditions

AML (Acute Myeloid Leukemia)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

selinexor (X), azacitidine (A), and venetoclax (B) - the XAB regimen

Group Type: EXPERIMENTAL

the XAB regimen

Intervention Type: DRUG

the XAB regimen: a chemotherapy-free or low-dose chemotherapy regimen containing selinexor (X), azacitidine (A), and venetoclax (B)

Interventions

the XAB regimen

the XAB regimen: a chemotherapy-free or low-dose chemotherapy regimen containing selinexor (X), azacitidine (A), and venetoclax (B)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Donghua Zhang

OTHER

Sponsor Role: lead

Responsible Party

Donghua Zhang

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

Central Contacts

Andie Fu

Role: CONTACT

andie_fu@163.com

15926614832

Facility Contacts

Andie Fu

Role: primary

andie_fu@163.com

15926614832

Other Identifiers

DHZ1962-B

Identifier Type: -

Identifier Source: org_study_id