Using selinexor with chemotherapy for 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

This study tests if adding selinexor to standard chemotherapy can help people with relapsed or refractory acute myeloid leukemia feel better and live longer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Shanxi Bethune Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Taiyuan, Shanxi)
• Trial ID: NCT05726110 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of selinexor when combined with either the HAD or CAG chemotherapy regimens in patients with relapsed or refractory acute myeloid leukemia. The study aims to evaluate various outcomes including complete and partial remission rates, recurrence rates, overall survival, and safety indicators such as treatment-related mortality and adverse events. Participants will be closely monitored to assess the impact of this combination therapy on their condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 with relapsed or refractory acute myeloid leukemia who meet specific diagnostic criteria.

Not a fit: Patients with acute myeloid leukemia subtype M3 or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve remission rates and overall survival for patients with difficult-to-treat acute myeloid leukemia.

How similar studies have performed: Other studies have shown promise with similar combination therapies, suggesting potential for success in this approach.

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.

Where this trial is running

Taiyuan, Shanxi

• Tao Wang — Taiyuan, Shanxi, China (Recruiting)

Study contacts

• Study coordinator: Tao Wang

Conditions Relapsed or Refractory Acute Myeloid Leukemia