AMLPhase 2NCT06741722
Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for R/R AML
A Phase 2 study testing Decitabine, Azacitidine, Mitoxantrone liposome, Cytarabine, G-CSF in people with AML and Relapsed Acute Myeloid Leukemia, run by Beijing 302 Hospital at 1 site in China.
Trial summary
The DCMG regimen includes decitabine or azacitidine (hypomethylating agents), mitoxantrone liposome, cytarabine, and granulocyte colony-stimulating factor (G-CSF), comprising four medications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- AML, Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- What is being tested?
- Decitabine, Azacitidine, Mitoxantrone liposome, Cytarabine, G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2024to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- 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;
- 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;
Show all 9Show fewer
- Echocardiogram showing left ventricular ejection fraction (LVEF) ≥ 50%;
- Estimated survival time ≥ 3 months;
- ECOG performance status score of 0-2.
Who cannot join
- The subject's prior anti-tumor treatment history meets one of the following conditions:
- 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);
- Cardiac function and disease meet any of the following conditions:
- Long QTc syndrome or QTc interval > 480 ms;
- Complete left bundle branch block, second-degree or third-degree atrioventricular block;
Show all 18Show fewer
- Severe, uncontrolled arrhythmia requiring medication;
- New York Heart Association (NYHA) classification ≥ Class II;
- Ejection fraction (EF) < 50% or below the lower limit of normal for the study center's laboratory;
- 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.
- Underwent any major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, or experimental treatment within 2 weeks before the first administration of the study drug;
- Uncontrolled systemic diseases (such as progressive infections, uncontrolled hypertension, diabetes, etc.);
- Previous or current diagnosis of other malignancies (excluding adequately controlled basal cell carcinoma of the skin that is non-melanoma, breast/cervical carcinoma in situ, or other malignancies that have been adequately controlled without treatment in the past five years);
- Active hepatitis B or C infection during the viremic phase (Hepatitis B testing: if either HBsAg or core antibody is positive, add HBV-DNA testing; viral DNA levels exceeding 1x10^3 copies/mL; Hepatitis C testing: if HCV antibody is positive, add HCV-RNA testing; viral RNA levels exceeding 1x10^3 copies/mL);
- Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);
- Pregnant women, breastfeeding women, patients who refuse to use effective contraception during the study period;
- Significant neurological or psychiatric history;
- Patients deemed unsuitable for participation in this study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing
Lei Xu, 86-01066947174, xulei800@hotmail.com
About this study
Official title: Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for Relapsed/refractory Acute Myeloid Leukemia
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.
- Being tested
- Decitabine, Azacitidine, Mitoxantrone liposome, Cytarabine, G-CSF
- Keywords
- AML, mitoxantrone liposome, Acute Myeloid Leukemia, relapsed/refractory AML, DCMG chemotherapy
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decitabine, Azacitidine, Mitoxantrone liposome, Cytarabine, G-CSFDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| DCMG | Experimental | Patients are treated with DCMG chemotherapy regimen. Receives: Drug: Decitabine, Azacitidine, Mitoxantrone liposome, Cytarabine, G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate
Percentage of subjects with complete remission (CR) and incomplete hematologic recovery (CRi)
Measured: At the end of Cycle 2 (each cycle is 28 days)
Secondary outcomes (4)
Relapse-Free Survival
Time interval from leukemia free state to the first recurrence or death
Measured: 24 months
Overall Survival
Time interval from start of treatment until death or last follow-up
Measured: 24 months
Duration of response
Measured: Time interval from morphologic/MRD response to loss of response or death
Adverse events
Number of subjects with each adverse event.
Measured: Start of treatment to 2 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start31 Oct 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Ning Gao, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741722
- Sponsor's protocol ID
- AML_DCMG_2024
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for Relapsed/refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06741722
- Acronym / sponsor ID
- AML_DCMG_2024
- Keywords
- AML, mitoxantrone liposome, Acute Myeloid Leukemia, relapsed/refractory AML, DCMG chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCMG | Experimental | Drug: Decitabine, Azacitidine, Mitoxantrone liposome, Cytarabine, G-CSFPatients are treated with DCMG chemotherapy regimen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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):
- 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%;
Key exclusion criteria (18 listed)
- The subject's prior anti-tumor treatment history meets one of the following conditions:
- Cardiac function and disease meet any of the following conditions:
- Underwent any major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, or experimental treatment within 2 weeks before the first administration of the study drug;
- Uncontrolled systemic diseases (such as progressive infections, uncontrolled hypertension, diabetes, etc.);
- Previous or current diagnosis of other malignancies (excluding adequately controlled basal cell carcinoma of the skin that is non-melanoma, breast/cervical carcinoma in situ, or other malignancies that have been adequately controlled without treatment in the past five years);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decitabine, Azacitidine, Mitoxantrone liposome, Cytarabine, G-CSFThe 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. | Drug | DCMG |
Primary outcome
Complete remission rate
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Percentage of subjects with complete remission (CR) and incomplete hematologic recovery (CRi)
4 secondary outcomes
Relapse-Free Survival
Time frame: 24 months
Overall Survival
Time frame: 24 months
Duration of response
Time frame: Time interval from morphologic/MRD response to loss of response or death
Adverse events
Time frame: Start of treatment to 2 weeks after end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for AML
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Decitabine, Azacitidine, Mitoxantrone liposome, Cytarabine, G-CSF in people with AML and Relapsed Acute Myeloid Leukemia, run by Beijing 302 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Gao Xiaoning, Chief Physician, Professor (86+01066947169, gaoxn@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate (time frame: At the end of Cycle 2 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.