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Clinical Trials in China / NCT05726110
Recruiting Phase 3

Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia

NCT05726110 · tracked via the Priya Life Science China tracker
Sponsor
Shanxi Bethune Hospital
Phase
Phase 3
Started
2023-01-29
Last updated
2024-10-22

Condition(s) studied

Relapsed or Refractory Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

SelinexorHomoharringtonineDaunorubicinCytarabineGranulocyte Colony-Stimulating FactorAclacinomycin

Selinexor: Given PO

Homoharringtonine: Given per standard of care

Daunorubicin: Given per standard of care

Cytarabine: Given per standard of care

Granulocyte Colony-Stimulating Factor: Given per standard of care

Aclacinomycin: Given per standard of care

Study summary

This clinical trial studies the efficacy and safety of selinexor combined with HAD or CAG regimen in the treatment of relapsed or refractory acute myeloid leukemia

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age:18-60 years old; 2. Except for patients with AML-M3 with acute myeloid leukemia; 3. Meet the diagnostic criteria for refractory AML (2011 Chinese guidelines for the diagnosis and treatment of acute myeloid leukemia (relapsed or refractory)):(1) The standard regimen did not achieve complete remission after 2 courses of induction chemotherapy;(2) Relapse within 6 months after the first complete remission; (3) Patients who relapse after 6 months after the first complete remission, and those who fail to induce chemotherapy after the original program; (4) 2 or more recurrences; (5) Extramedullary leukemia persists; 4. Meet the diagnostic criteria for recurrent AML (refer to the 2014 NCCN guidelines): after complete remission, (1) naive cells appear in peripheral blood; (2) \>5% of bone marrow naive cells; (3) Extramedullary recurrence; 5. The bone marrow image indicates active hyperplasia or hypoproliferation; 6. Eastern Oncology Collaborative Group Physical Status Assessment (ECOG-PS) with a score of 0-2. Exclusion Criteria: 1. Accompanied by cerebral hemorrhage; 2. Pregnancy; 3. Have a mental illness or other condition that cannot proceed as planned; 4. Severe arrhythmia, abnormal ECG (QT\>500ms). Early withdrawal from test criteria: Participants have the right to withdraw from the study at any time from the trial. Exit Criteria: 1. The subject or the subject's legally authorized representative requests to withdraw from the study; 2. Participant loss to follow-up. Doctor/Investigator required subjects to terminate the trial early: 1. Subjects who are unable to carry out follow-up treatment due to adverse events (serious irreversible organ function damage during treatment) who are judged by the investigator to be unsuitable for continuing the research; 2. The subject does not adhere to the protocol, such as the use of chemotherapy drugs, etc., which affects the effectiveness and safety judgment. For participants who withdrew early from the study (except subjects who were lost to follow-up), the reason for their early withdrawal should be recorded, and the time of the last study's medication/treatment should be recorded, and the examination items at the time of early withdrawal from the study should be completed at the last visit, if possible.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tao Wang Taiyuan Shanxi Recruiting

More Shanxi Bethune Hospital trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05726110 on ClinicalTrials.gov ↗ ← All trials in China