Loading clinical trials...

Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for R/R AML | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for R/R AML

Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for Relapsed/refractory Acute Myeloid Leukemia

NCT06741722•Beijing 302 Hospital

View on ClinicalTrials.gov

Summary

The DCMG regimen includes decitabine or azacitidine (hypomethylating agents), mitoxantrone liposome, cytarabine, and granulocyte colony-stimulating factor (G-CSF), comprising four medications. This project initiates a prospective and exploratory clinical study on the DCMG chemotherapy regimen for the treatment of relapsed/refractory AML (Acute Myeloid Leukemia). The study aims to evaluate the efficacy and safety of the DCMG combination chemotherapy regimen in treating relapsed/refractory AML.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The patient has fully understood the study, voluntarily agrees to participate, and has signed the Informed Consent Form (ICF);
•Age between 18 and 75 years, with no gender restrictions;
•Confirmed diagnosis of relapsed/refractory AML (Acute Myeloid Leukemia) by pathology (meeting any one of the following criteria):
•1. Patients who meet the diagnostic criteria for acute myeloid leukemia (AML) with minimal residual disease (MRD) positivity;
•2. Or patients who meet the diagnostic criteria for recurrent AML, or refractory AML;
•Serum total bilirubin ≤ 1.5 times the upper limit of normal, serum ALT and AST both ≤ 2.5 times the upper limit of the normal range, serum creatinine ≤ 1.5 times the upper limit of normal;
•Echocardiogram showing left ventricular ejection fraction (LVEF) ≥ 50%;
•Estimated survival time ≥ 3 months;
•ECOG performance status score of 0-2.

Exclusion Criteria

•The subject's prior anti-tumor treatment history meets one of the following conditions:
•1. Previously received mitoxantrone or mitoxantrone hydrochloride liposome injection;
•2. Previously received doxorubicin or other anthracyclines, with a total cumulative dose of doxorubicin \> 360 mg/m² (other anthracycline drugs are converted at a ratio of 1 mg doxorubicin equivalent to 2 mg daunorubicin or 0.5 mg idarubicin);
•Cardiac function and disease meet any of the following conditions:
•1. Long QTc syndrome or QTc interval \> 480 ms;
•2. Complete left bundle branch block, second-degree or third-degree atrioventricular block;
•3. Severe, uncontrolled arrhythmia requiring medication;
•4. New York Heart Association (NYHA) classification ≥ Class II;
•5. Ejection fraction (EF) \< 50% or below the lower limit of normal for the study center's laboratory;
•6. History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmia requiring treatment, clinically significant pericardial disease, or evidence on electrocardiogram of acute ischemia or active conduction system abnormalities within 6 months prior to enrollment.
+8 more criteria

Locations (1)

Chinese PLA General Hospital

Beijing, China

Key Dates

Start Date

October 31, 2024

Primary Completion Date

October 31, 2026

Completion Date

December 31, 2027

Last Updated

December 27, 2024

Enrollment

ESTIMATED participants

Conditions

AMLRelapsed Acute Myeloid LeukemiaRefractory Acute Myeloid Leukemia

Interventions

Decitabine, Azacitidine, Mitoxantrone liposome, Cytarabine, G-CSF

DRUG

Contacts

Dr. Gao Xiaoning, Chief Physician, Professor

CONTACT

86+01066947169 gaoxn@263.net

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

NCT06859424

AML (Acute Myelogenous Leukemia)Acute Lymphoid Leukemia (ALL)+9 more

View study

RECRUITINGPHASE1

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

NCT06484062

Acute Myeloid LeukemiaMyelodysplastic Syndrome+7 more

View study

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: December 27, 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

Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for R/R AML

Inclusion Criteria

Exclusion Criteria

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias

SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation

A Phase 1 Study of AOH1996 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors