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

NCT05726110 | Recruiting Phase 3

• 1 other identifier: ShanxiBethuneH
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Relapsed or Refractory Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Remission Rate

  complete remission rate(CR rate), partial remission rate (PR rate) , no remission rate (NR rate)

  max 2 years

Secondary Outcomes (5)

• Recurrence Rate

  max 2 years

• Treatment-Related Mortality (TRM)

  max 2 years

• Overall Survival (OS)

  max 2 years

• Event-Free Survival (EFS)

  max 2 years

• Safety:Incidence and severity of adverse events

  max 2 years

Study Arms (1)

Selinexor、HAD or CAG regimens

EXPERIMENTAL

* Selinexor (60 mg) is used twice weekly for two weeks (four times, 240 mg total of selinexor) in combination with HAD or CAG regimens for reinduction therapy in patients with relapsed and refractory AML. * (Bone marrow image indicates active hyperplasia) HAD regimen: homoharringtonine (HHT) (2mg/ m\^2/d)×7days, daunorubicin (DNR, 40mg/ m\^2/d)×3 days, cytarabine (Ara-C,100-200mg/ m\^2/d)×7 days (no leukocyte drugs should be used throughout the treatment process)； * (Bone marrow image indicates hypoproliferation)CAG regimen: Granulocyte Colony-Stimulating Factor (G-CSF, 5ug/kg/d, started 12 hours before chemotherapy×14 days (d1-d14), aclacinomycin (20mg/d)×4 days (d1-4), cytarabine (10 mg/ m\^2, subcutaneous injection, 1 time in 12 hours)×14 days (d1-d14). * G-CSF was discontinued in the CAG regimen when WBC \> 20×10\^9/L, but chemotherapy was not stopped.

Drug: Selinexor; Drug: Homoharringtonine; Drug: Daunorubicin; Drug: Cytarabine; Drug: Granulocyte Colony-Stimulating Factor; Drug: Aclacinomycin

Interventions

Selinexor DRUG

Given PO

Also known as: KPT-330

Selinexor、HAD or CAG regimens

Homoharringtonine DRUG

Given per standard of care

Also known as: HHT

Selinexor、HAD or CAG regimens

Daunorubicin DRUG

Given per standard of care

Also known as: DNR

Selinexor、HAD or CAG regimens

Cytarabine DRUG

Given per standard of care

Also known as: Ara-C

Selinexor、HAD or CAG regimens

Granulocyte Colony-Stimulating Factor DRUG

Given per standard of care

Also known as: G-CSF

Selinexor、HAD or CAG regimens

Aclacinomycin DRUG

Given per standard of care

Also known as: ACM

Selinexor、HAD or CAG regimens

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanxi Bethune Hospital: lead
• Antengene Corporation: collaborator

Study Sites (1)

Tao Wang

Taiyuan, Shanxi, 030000, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Leukemia, Myeloid, Acute

Interventions

selinexor; Homoharringtonine; Daunorubicin; Cytarabine; Granulocyte Colony-Stimulating Factor; aclacinomycins

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Harringtonines; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Tao Wang

  Shanxi Bethune Hospital Regulatory Authority

  STUDY DIRECTOR

Central Study Contacts

Tao Wang

CONTACT

13835175119; wangtao99699@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 13, 2023
• Study Start: January 29, 2023
• Primary Completion: December 10, 2024
• Study Completion: December 31, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

CN (1)