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

October 20, 2024 updated by: Shanxi Bethune Hospital

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 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • Tao Wang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Selinexor、HAD or CAG regimens
  • 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
Given PO
Other Names:
  • KPT-330
Drug: Cytarabine
Given per standard of care
Other Names:
  • Ara-C
Drug: Homoharringtonine
Given per standard of care
Other Names:
  • HHT
Drug: Daunorubicin
Given per standard of care
Other Names:
  • DNR
Drug: Granulocyte Colony-Stimulating Factor
Given per standard of care
Other Names:
  • G-CSF
Drug: Aclacinomycin
Given per standard of care
Other Names:
  • ACM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission Rate
Time Frame: max 2 years
complete remission rate(CR rate), partial remission rate (PR rate) , no remission rate (NR rate)
max 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Rate
Time Frame: max 2 years
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
Treatment-Related Mortality (TRM)
Time Frame: max 2 years
A death that is considered to be causally linked to a treatment
max 2 years
Overall Survival (OS)
Time Frame: max 2 years
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
Event-Free Survival (EFS)
Time Frame: max 2 years
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
Safety:Incidence and severity of adverse events
Time Frame: max 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanxi Bethune Hospital

Collaborators

Antengene Corporation

Investigators

  • Study Director: Tao Wang, Shanxi Bethune Hospital Regulatory Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2023

Primary Completion (Estimated)

December 10, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 29, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (Actual)

February 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 20, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanxiBethuneH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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