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Clinical study of Chemotherapy-free or Low-dose Chemotherapy regimen containing Selinexor in the treatment of relapsed/refractory acute myeloid leukemia

Clinical study of Chemotherapy-free or Low-dose Chemotherapy regimen containing Selinexor in the treatment of relapsed/refractory acute myeloid leukemia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077623
Enrollment
Unknown
Registered
2023-11-14
Start date
2023-11-15
Completion date
Unknown
Last updated
2023-11-21

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

Conditions

Relapsed/Refractory Acute Myeloid Leukemia

Interventions

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Clinically diagnosed patients with relapsed refractory acute myeloid leukemia (R/R AML) (2) Age: 18-60 years old; (3) no serious damage to the function of major organs of the whole body; (4) No history of drug allergy in the program (5) Participants planning to become pregnant must agree to use contraception before entering the study and after six months of study duration; Notify the investigator immediately if the subject is pregnant or suspected to be pregnant; (6) The subject understands and signs the informed consent;

Exclusion criteria

Exclusion criteria: (1) Confirmed diagnosis of acute myeloid leukemia type M3; (2) 60 years old; (3) There are basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated liver insufficiency, renal function, gastrointestinal insufficiency, etc. (4) Clinically uncontrolled active infections (including bacterial, fungal, or viral infections) that do not respond to medical treatment; (5) Participating in other clinical studies, or plan to start this study treatment less than 4 weeks from the end of the previous clinical study treatment (6) Patients with other malignant tumors requiring treatment; (7) Allergy to the drugs in the program; (8) The female subject is pregnant or lactating; (9) Human immunodeficiency virus (HIV) infection or syphilis infection; (10) Active hepatitis that remains uncontrolled after active antiviral therapy (positive for hepatitis B virus deoxyribonucleic acid [HBV DNA] or hepatitis C virus RNA [HCV RNA]); (11) Persistent COVID-19 positive patients (excluding positive patients who have turned negative); (12) Circumstances that the investigator believes may increase the risk to the subject or interfere with the test results.

Design outcomes

Primary

MeasureTime frame
complete remission rate;

Secondary

MeasureTime frame
overall response rate;transplantation rate;Overall survival;Relapse free survival;MRD negative rate;

Countries

China

Contacts

Public ContactDonghua Zhang

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

zdh_62@126.com+86 27 8366 2830

Outcome results

None listed

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