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

ConditionsAMLRelapsed Acute Myeloid LeukemiaRefractory Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing 302 Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Patients who meet the diagnostic criteria for acute myeloid leukemia (AML) with minimal residual disease (MRD) positivity;

Or patients who meet the diagnostic criteria for recurrent AML, or refractory AML;

Disqualifiers

Previously received mitoxantrone or mitoxantrone hydrochloride liposome injection;

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);

Long QTc syndrome or QTc interval > 480 ms;

Complete left bundle branch block, second-degree or third-degree atrioventricular block;

Trial design

Design model

Single group

Treatments tested in this trial

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

    Drug

    The specific administration times and dosages for the DCMG chemotherapy regimen are as follows: M: Mitoxantrone Hydrochloride Liposome Injection: 15 mg/m², IV, on Day 1, every 4 weeks (q4w); D: Decitabine: 20 mg/m², IV, Days 1-5, q4w; (or Azacitidine: 75 mg/m², IV, Days 1-7, q4w); C: Cytarabine: 100 mg, IV, every 12 hours on Days 1-5, q4w; For patients with hypoplastic bone marrow, the dose of cytarabine injection is 10 mg, every 12 hours, q4w; G: G-CSF: 5 μg/kg, subcutaneous injection, from Day 0 until the white blood cell count exceeds 10.0×10\^9/L, at which point chemotherapy is stopped; or Pegylated Recombinant Human Granulocyte Stimulating Factor Injection: 100 μg/kg, subcutaneous injection, on Day 0. One cycle lasts for 4 weeks, with a planned administration of 1 or 2 cycles.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: DCMGExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete remission rate

Percentage of subjects with complete remission (CR) and incomplete hematologic recovery (CRi)

Time frame
At the end of Cycle 2 (each cycle is 28 days)

Secondary outcomes

1

Relapse-Free Survival

Time interval from leukemia free state to the first recurrence or death

Time frame
24 months
2

Overall Survival

Time interval from start of treatment until death or last follow-up

Time frame
24 months
3

Duration of response

Time frame
Time interval from morphologic/MRD response to loss of response or death
4

Adverse events

Number of subjects with each adverse event.

Time frame
Start of treatment to 2 weeks after end of treatment

Other outcomes

Sponsors and contacts

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

Beijing 302 Hospital

Lead sponsor

Source ClinicalTrials.gov
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