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Recruiting NCT05726110

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

Phase III Interventional Relapsed or Refractory Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Selinexor, Homoharringtonine, Daunorubicin, Cytarabine.
Who it may be relevant to
Registry conditions: Relapsed or Refractory Acute Myeloid Leukemia. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Selinexor
    Given PO
  • Drug Homoharringtonine
    Given per standard of care
  • Drug Daunorubicin
    Given per standard of care
  • Drug Cytarabine
    Given per standard of care
  • Drug Granulocyte Colony-Stimulating Factor
    Given per standard of care
  • Drug Aclacinomycin
    Given per standard of care

Primary outcome measures

  • Remission Rate [Time frame: max 2 years]
Secondary outcome measures (5)
  • Recurrence Rate [Time frame: max 2 years]
  • Treatment-Related Mortality (TRM) [Time frame: max 2 years]
  • Overall Survival (OS) [Time frame: max 2 years]
  • Event-Free Survival (EFS) [Time frame: max 2 years]
  • Safety:Incidence and severity of adverse events [Time frame: max 2 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tao Wang — Taiyuan

Identifiers

NCT: NCT05726110 · ShanxiBethuneH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗