Clinical trial NCT05726110: Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia
Official title: A Single-arm Open-label Multicenter Clinical Study of Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Relapsed or Refractory Acute Myeloid Leukemia
Lead sponsor: Shanxi Bethune Hospital
Sponsor class: OTHER
Collaborators: name: Antengene Corporation
First posted: 2023-02-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Remission Rate
timeFrame: max 2 years
Secondary outcomes:
measure: Recurrence Rate
timeFrame: max 2 years
measure: Treatment-Related Mortality (TRM)
timeFrame: max 2 years
measure: Overall Survival (OS)
timeFrame: max 2 years
measure: Event-Free Survival (EFS)
timeFrame: max 2 years
measure: Safety:Incidence and severity of adverse events
timeFrame: max 2 years
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Tao Wang
state: Shanxi
Study officials:
affiliation: Shanxi Bethune Hospital Regulatory Authority
name: Tao Wang
role: STUDY_DIRECTOR
References: