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Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

A Single-arm Open-label Multicenter Clinical Study of Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia

NCT05726110•Shanxi Bethune Hospital

View on ClinicalTrials.gov

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

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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 more criteria

Locations (1)

Tao Wang

Taiyuan, Shanxi, China

Key Dates

Start Date

January 29, 2023

Primary Completion Date

December 10, 2024

Completion Date

December 31, 2024

Last Updated

October 22, 2024

Enrollment

ESTIMATED participants

Conditions

Relapsed or Refractory Acute Myeloid Leukemia

Interventions

Selinexor

DRUG

Homoharringtonine

DRUG

Daunorubicin

DRUG

Cytarabine

DRUG

Granulocyte Colony-Stimulating Factor

DRUG

Aclacinomycin

DRUG

Contacts

Tao Wang

CONTACT

13835175119 wangtao99699@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

BCL2i CLAG-M in R/R Acute Myeloid Leukemia

Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

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Phase II Study of Crenolanib in Subjects With Relapsed/Refractory AML With FLT3 Activating Mutations