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

Relapsed or Refractory Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726110
• Other study ID #: ShanxiBethuneH
• Status: Recruiting
• Phase: Phase 3
• Start date: January 29, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Shanxi Bethune Hospital
• Contact: Tao Wang
• Phone: 13835175119
• Email: wangtao99699[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Relapsed or Refractory Acute Myeloid Leukemia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Tao Wang	Taiyuan	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
Shanxi Bethune Hospital	Antengene Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission Rate	complete remission rate(CR rate), partial remission rate (PR rate) , no remission rate (NR rate)	max 2 years
Secondary	Recurrence Rate	After complete remission, (1) naive cells appear in peripheral blood; (2) >5% of bone marrow naive cells; (3) Extramedullary recurrence(refer to the 2014 NCCN guidelines).	max 2 years
Secondary	Treatment-Related Mortality (TRM)	A death that is considered to be causally linked to a treatment	max 2 years
Secondary	Overall Survival (OS)	Overall survival is a secondary endpoint that will be measured as time from the start of treatment until death from any cause, or the last date the patient was known to be alive	max 2 years
Secondary	Event-Free Survival (EFS)	Event-free survival (EFS) was calculated from the time of informed consent until death, not achieving CR/CRi or relapse after CR/CRi.	max 2 years
Secondary	Safety:Incidence and severity of adverse events	To evaluate the possible adverse events and deaths during treatment with selinexor in combination with HAD or CAG,mainly including liver toxicity, cardiotoxicity, bacterial infection, viral infection, fungal infection.	max 2 years