AMLNCT06758726
Mitoxantrone Hydrochloride Liposome Combined With BU/Cy Were Used as a Conditioning Regimen for Patients With Intermediate/Adverse Risk or Persistently Positive MRD AML
A study testing Mitoxantrone Hydrochloride Liposome combined with BU/Cy in people with AML, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
The goal of this study is to evaluate the efficacy and safety of a conditioning regimen of Mitoxantrone Hydrochloride Liposome in combination with Bu/Cy (M+Bu/Cy) on acute myeloid leukaemia (AML) patients with intermediate/adverse risk disease or persistently positive MRD undergoing allogeneic haematopoietic stem-cell… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- AML
- What is being tested?
- Mitoxantrone Hydrochloride Liposome combined with BU/Cy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2024to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1.Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
- 2. Age: 18-60 years (including 18 and 60 years) 3. Clinically diagnosed AML, excluding acute promyelocytic leukemia. Patients with at least one or more characteristics can be enrolled:
- AML patients with intermediate/adverse risk disease according to 2022 ELN recommendations.
- AML patients with persistently positive MRD before allo-HSCT. 4. Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2. 5. Negative HIV, HBV and HCV. 6. Before the research procedure begins, an ICF must be signed by the patient himself or a close relative. Considering the patient's condition, if signing the ICF by himself is not beneficial to the treatment of the disease, then the legal guardian or a close relative of the patient sign it.
Who cannot join
- 1. Relapsed/refractory AML. 2. Prior therapy with doxorubicin or other anthracyclines, and the cumulative dose of doxorubicin > 360 mg/m^2 (1 mg doxorubicin was equivalent to 2 mg daunorubicin or 0.5 mg idarubicin).
- 3. Cardiovascular diseases, including but not limited to:
- QTc interval >480 ms or long QTc syndrome in screening;
- Complete left bundle branch block, 2 or 3 grade atrioventricular block;
- Requiring treatment of serious and uncontrolled arrhythmia;
- New York Heart Association (NYHA≥2);
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- Cardiac ejection fraction (EF) was less than 50%;
- Myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other history of arrhythmia or clinically serious pericardial disease that requires treatment within the first 6 months of enrollment, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
- 4. Previous or current occurrence of other malignancies (in addition to non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years).
- 5. Subjects are suffering from any other uncontrollable disease (including but not limited to: uncontrolled diabetes and hypertension, and advanced infection).
- 6. HIV infection. 7. HBsAg or HBcAb positive, with HBV-DNA≥1x10^3 copies/mL; or HCV-RNA≥1x10^3 copies/mL; 8. Uncontrollable infection, mechanical assisted ventilation or hemodynamic instability at enrollment.
- 9. Clinically significant severe liver insufficiency (defined as grade C by Child-Pugh), AST or ALT was 5 times higher than the upper limit of normal (ULN), or serum total bilirubin was 2 times higher than the ULN within 5 days prior to enrollment.
- 10. End-stage renal insufficiency was diagnosed with creatinine clearance of less than 10ML/min within 5 days prior to enrollment.
- 11. Moderate hepatic insufficiency and moderate renal insufficiency were simultaneously diagnosed (moderate hepatic insufficiency was defined ash grade B by Child-Pug; Moderate renal insufficiency is defined as creatinine clearance of less than 50ML/min).
- 12. A history of immediate or delayed allergy to similar drug and excipients of the investigate drug.
- 13. Pregnant, lactating female or subjects who refuse to use effective contraception during the study.
- 14. With a history of severe neurological or psychiatric illness. 15. Not suitable for this study as decided by the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Mitoxantrone Hydrochloride Liposome Injection Combined With Bu/Cy Conditioning on Acute Myeloid Leukaemia Patients With Intermediate/Adverse Risk Disease or Persistently Positive MRD Undergoing Allogeneic Haematopoietic Stem-cell Transplantation: a Prospective, Single-center, Exploratory Clinical Study
The goal of this study is to evaluate the efficacy and safety of a conditioning regimen of Mitoxantrone Hydrochloride Liposome in combination with Bu/Cy (M+Bu/Cy) on acute myeloid leukaemia (AML) patients with intermediate/adverse risk disease or persistently positive MRD undergoing allogeneic haematopoietic stem-cell transplantation (allo-HSCT)
Read the detailed description
The goal of this study is to evaluate the efficacy and safety of a conditioning regimen of Mitoxantrone Hydrochloride Liposome in combination with Bu/Cy (M+Bu/Cy) on acute myeloid leukaemia (AML) patients with intermediate/adverse risk disease or persistently positive MRD undergoing allogeneic haematopoietic stem-cell transplantation (allo-HSCT Mitoxantrone Hydrochloride Liposome combined with BU/Cy were used as a conditioning regimen for patients with intermediate/adverse risk or persistently positive MRD AML.
Mitoxantrone hydrochloride liposome (30 mg/m^2) on day -9, iv Busulfan (3.2mg/kg/d) on day -7~-5, iv Cyclophosphamide (60 mg/kg/d) on day -3~-2, iv
- Conditions
- AML
- Being tested
- Mitoxantrone Hydrochloride Liposome combined with BU/Cy
- Keywords
- allo-HSCT, MRD+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone Hydrochloride Liposome combined with BU/CyDrug
Mitoxantrone hydrochloride liposome (30 mg/m^2) on day -9, iv Busulfan (3.2mg/kg/d) on day -7~-5, iv Cyclophosphamide (60 mg/kg/d) on day -3~-2, iv
| Study group | Role | What they receive |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome combined with BU/Cy | Other | Mitoxantrone Hydrochloride Liposome combined with BU/Cy were used as a conditioning regimen for patients with intermediate/adverse risk or persistently positive MRD AML. Receives: Drug: Mitoxantrone Hydrochloride Liposome combined with BU/Cy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year-relapsed free survival (1y-RFS)
RFS was defined as time from achieving remission until disease relapse or disease progression.
Measured: 1YEAR
Secondary outcomes (7)
1 year-overall survival (1y-OS)
OS was defined as time from conditioning treatment until death from any cause.
Measured: 1YEAR
1 year-non-relapse mortality (1y-NRM)
NRM was defined as death from any cause not subsequent to relapse or disease progression.
Measured: 1YEAR
1 year-cumulative incidence of relapse (1y-CIR)
CIR was defined as time from conditioning treatment until relapse or disease progression.
Measured: 1YEAR
Time of neutrophil and platelet engraftment
Neutrophil engraftment was defined as the first of 3 consecutive days with absolute neutrophil counts exceeding 0.5×109 cells per L, and platelet engraftment as the first of 3 consecutive days with absolute platelet counts exceeding 20×109 platelets per L without a platelet transfusion.
Measured: 8 weeks
Complete response (CR) rate
CR rate was defined as bone marrow blasts less than 5% with normal maturation of all cell lines, absence of circulating blasts and blasts with Auer rods, absence of extramedullary disease, and absolute neutrophil count ≥1×109 cells per L, platelet count ≥100×109 platelets per L.
Measured: 1YEAR
Incidence of adverse events
Adverse events were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0) except for GVHD; aGVHD and cGVHD were graded according to published guidelines.
Measured: 14 weeks
Regimenrelated toxicity (RRT)
RRT was assessed within 28 days after transplantation and graded according to Bearman's criteria.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start31 Dec 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (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.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758726
- Sponsor's protocol ID
- IIT2024064
- Status last verified
- Sep 2024
- First submitted
- 23 Oct 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitoxantrone Hydrochloride Liposome Injection Combined With Bu/Cy Conditioning on Acute Myeloid Leukaemia Patients With Intermediate/Adverse Risk Disease or Persistently Positive MRD Undergoing Allogeneic Haematopoietic Stem-cell Transplantation: a Prospective, Single-center, Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT06758726
- Acronym / sponsor ID
- IIT2024064
- Conditions
- AML
- Keywords
- allo-HSCT, MRD+
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 6 Jan 2025 (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 goal of this study is to evaluate the efficacy and safety of a conditioning regimen of Mitoxantrone Hydrochloride Liposome in combination with Bu/Cy (M+Bu/Cy) on acute myeloid leukaemia (AML) patients with intermediate/adverse risk disease or persistently positive MRD undergoing allogeneic haematopoietic stem-cell transplantation (allo-HSCT)
Detailed description
The goal of this study is to evaluate the efficacy and safety of a conditioning regimen of Mitoxantrone Hydrochloride Liposome in combination with Bu/Cy (M+Bu/Cy) on acute myeloid leukaemia (AML) patients with intermediate/adverse risk disease or persistently positive MRD undergoing allogeneic haematopoietic stem-cell transplantation (allo-HSCT Mitoxantrone Hydrochloride Liposome combined with BU/Cy were used as a conditioning regimen for patients with intermediate/adverse risk or persistently positive MRD AML.
Mitoxantrone hydrochloride liposome (30 mg/m^2) on day -9, iv Busulfan (3.2mg/kg/d) on day -7~-5, iv Cyclophosphamide (60 mg/kg/d) on day -3~-2, iv
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome combined with BU/Cy | Other | Drug: Mitoxantrone Hydrochloride Liposome combined with BU/CyMitoxantrone Hydrochloride Liposome combined with BU/Cy were used as a conditioning regimen for patients with intermediate/adverse risk or persistently positive MRD AML. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1.Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
- 2. Age: 18-60 years (including 18 and 60 years) 3. Clinically diagnosed AML, excluding acute promyelocytic leukemia. Patients with at least one or more characteristics can be enrolled:
Key exclusion criteria (17 listed)
- 1. Relapsed/refractory AML. 2. Prior therapy with doxorubicin or other anthracyclines, and the cumulative dose of doxorubicin > 360 mg/m^2 (1 mg doxorubicin was equivalent to 2 mg daunorubicin or 0.5 mg idarubicin).
- 4. Previous or current occurrence of other malignancies (in addition to non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years).
- 5. Subjects are suffering from any other uncontrollable disease (including but not limited to: uncontrolled diabetes and hypertension, and advanced infection).
- 6. HIV infection. 7. HBsAg or HBcAb positive, with HBV-DNA≥1x10^3 copies/mL; or HCV-RNA≥1x10^3 copies/mL; 8. Uncontrollable infection, mechanical assisted ventilation or hemodynamic instability at enrollment.
- 9. Clinically significant severe liver insufficiency (defined as grade C by Child-Pugh), AST or ALT was 5 times higher than the upper limit of normal (ULN), or serum total bilirubin was 2 times higher than the ULN within 5 days prior to enrollment.
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 |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome combined with BU/CyMitoxantrone hydrochloride liposome (30 mg/m^2) on day -9, iv Busulfan (3.2mg/kg/d) on day -7~-5, iv Cyclophosphamide (60 mg/kg/d) on day -3~-2, iv | Drug | Mitoxantrone Hydrochloride Liposome combined with BU/Cy |
Primary outcome
1 year-relapsed free survival (1y-RFS)
Time frame: 1YEAR
RFS was defined as time from achieving remission until disease relapse or disease progression.
7 secondary outcomes
1 year-overall survival (1y-OS)
Time frame: 1YEAR
1 year-non-relapse mortality (1y-NRM)
Time frame: 1YEAR
1 year-cumulative incidence of relapse (1y-CIR)
Time frame: 1YEAR
Time of neutrophil and platelet engraftment
Time frame: 8 weeks
Complete response (CR) rate
Time frame: 1YEAR
Incidence of adverse events
Time frame: 14 weeks
Regimenrelated toxicity (RRT)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Mitoxantrone Hydrochloride Liposome combined with BU/Cy in people with AML, run by Institute of Hematology & Blood Diseases Hospital, 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 4 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact erlie jiang (15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year-relapsed free survival (1y-RFS) (time frame: 1YEAR). 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 6 Jan 2025.