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

ConditionRelapsed or Refractory Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShanxi Bethune Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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；

Disqualifiers

Accompanied by cerebral hemorrhage；

Pregnancy；

Have a mental illness or other condition that cannot proceed as planned；

Severe arrhythmia, abnormal ECG (QT>500ms).

Trial design

Design model

Single group

Treatments tested in this trial

  • Selinexor

    Drug

    Given PO

  • Homoharringtonine

    Drug

    Given per standard of care

  • Daunorubicin

    Drug

    Given per standard of care

  • Cytarabine

    Drug

    Given per standard of care

  • Granulocyte Colony-Stimulating Factor

    Drug

    Given per standard of care

  • Aclacinomycin

    Drug

    Given per standard of care

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Selinexor、HAD or CAG regimensExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Remission Rate

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

Time frame
max 2 years

Secondary outcomes

1

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).

Time frame
max 2 years
2

Treatment-Related Mortality (TRM)

A death that is considered to be causally linked to a treatment

Time frame
max 2 years
3

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

Time frame
max 2 years
4

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.

Time frame
max 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanxi Bethune Hospital

Lead sponsor

Antengene Corporation

Collaborator

Source ClinicalTrials.gov
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