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Trial Title:
Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia
NCT ID:
NCT05726110
Condition:
Relapsed or Refractory Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cytarabine
Daunorubicin
Homoharringtonine
Aclacinomycins
Lenograstim
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Selinexor
Description:
Given PO
Arm group label:
Selinexor、HAD or CAG regimens
Other name:
KPT-330
Intervention type:
Drug
Intervention name:
Homoharringtonine
Description:
Given per standard of care
Arm group label:
Selinexor、HAD or CAG regimens
Other name:
HHT
Intervention type:
Drug
Intervention name:
Daunorubicin
Description:
Given per standard of care
Arm group label:
Selinexor、HAD or CAG regimens
Other name:
DNR
Intervention type:
Drug
Intervention name:
Cytarabine
Description:
Given per standard of care
Arm group label:
Selinexor、HAD or CAG regimens
Other name:
Ara-C
Intervention type:
Drug
Intervention name:
Granulocyte Colony-Stimulating Factor
Description:
Given per standard of care
Arm group label:
Selinexor、HAD or CAG regimens
Other name:
G-CSF
Intervention type:
Drug
Intervention name:
Aclacinomycin
Description:
Given per standard of care
Arm group label:
Selinexor、HAD or CAG regimens
Other name:
ACM
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
Detailed description:
Main Purpose：
To observe the efficacy of selinexor in combination with HAD or CAG regimen for relapsed
and refractory acute myeloid leukemia :complete remission rate (CR rate), partial
remission rate (PR rate), no remission rate (NR rate), complete remission with incomplete
hematologic recovery(CRi rate)
Secondary Purposes：
1. To observe the recurrence rate of selinexor combined with HAD or CAG regimen for
relapsed and refractory acute myeloid leukemia, treatment-related mortality(TRM),
Overall Survival (OS), Event-Free Survival (EFS);
2. Safety indicators: to observe adverse events and deaths during treatment with
selinexor in combination with HAD or CAG regimen.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tao Wang
Address:
City:
Taiyuan
Zip:
030000
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Wang, doctorial
Phone:
13835175119
Email:
wangtao99699@163.com
Start date:
January 29, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Shanxi Bethune Hospital
Agency class:
Other
Collaborator:
Agency:
Antengene Corporation
Agency class:
Industry
Source:
Shanxi Bethune Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05726110
