RecruitingPhase 3NCT05726110
Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia
A Single-arm Open-label Multicenter Clinical Study of Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia
Sponsor
Shanxi Bethune Hospital
Enrollment
50 participants
Start Date
Jan 29, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 60 Years
Inclusion Criteria6
- Age:18-60 years old;
- Except for patients with AML-M3 with acute myeloid leukemia；
- 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；
- 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；
- The bone marrow image indicates active hyperplasia or hypoproliferation；
- Eastern Oncology Collaborative Group Physical Status Assessment (ECOG-PS) with a score of 0-2.
Exclusion Criteria12
- Accompanied by cerebral hemorrhage；
- Pregnancy；
- Have a mental illness or other condition that cannot proceed as planned；
- 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:
- The subject or the subject's legally authorized representative requests to withdraw from the study;
- Participant loss to follow-up.
- Doctor/Investigator required subjects to terminate the trial early:
- 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;
- 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.
Interventions
DRUGSelinexor
Given PO
DRUGHomoharringtonine
Given per standard of care
DRUGDaunorubicin
Given per standard of care
DRUGCytarabine
Given per standard of care
DRUGGranulocyte Colony-Stimulating Factor
Given per standard of care
DRUGAclacinomycin
Given per standard of care
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05726110
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