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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115114
Enrollment
Unknown
Registered
2025-12-23
Start date
2024-12-30
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Interventions

Experimental Group:Eligible patients with AML who had hyperleukocytosis were treated with cerinissol-containing regimens without or at a low dose when the white-cell count was reduced to less than 10×

Sponsors

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Newly diagnosed acute myeloid leukemia (AML) patients Ineligible or unwilling to receive intensive chemotherapy . (1) Patients 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 =30 mL/min to 1.5 to =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

Exclusion criteria: 1.A definitive diagnosis of APL. 2.Age =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 treatment 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 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.

Design outcomes

Primary

MeasureTime frame
Overall surviva;;

Secondary

MeasureTime frame
Relapse-free Survival;Complete response with incomplete hematologic recovery;Relapse;Leukemia-free bone marrow status;Partial response;Complete response;

Countries

China

Contacts

Public ContactDonghua Zhang

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

zdh_62@126.com+86 27 8366 2688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026