Acute Myeloid LeukaemiaPhase 3NCT06345365

MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

A Phase 3 study testing mitoxantrone liposome, Ara-Cytarabine and azacitidine and Daunorubicin,Ara-Cytarabine, azacitidine in people with Acute Myeloid Leukaemia, run by Zhongnan Hospital at 11 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Investigator proposed to apply the new dosage form of mitoxantrone hydrochloride liposomes to the clinical treatment of AML, while combining with cytarabine and azacitidine to form the MA+AZA treatment regimen(Mitoxantrone liposome +Ara-Cytarabine+Azacitidine), which would provide an optimal induction treatment… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Acute Myeloid Leukaemia
What is being tested?: mitoxantrone liposome, Ara-Cytarabine and azacitidine and Daunorubicin,Ara-Cytarabine, azacitidine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 154 participants
Where: 11 sitesChina
Study dates: 18 Jan 2024to 31 Dec 2028
Phase: Phase 3
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

Patients with primary AML with morphologically and immunologically confirmed diagnosis of bone marrow;
Age 18-75 years old;
Liver and renal function: serum total bilirubin ≤1.5 × upper limit of normal (ULN), AST/ALT <2 × ULN, serum creatinine <1.5 × ULN, 80 ml/min ≤ creatinine clearance ≤120 ml/min;
Cardiac function: ejection fraction EF ≥50%, ultrasensitive troponin and natriuretic peptide <1.5 × ULN;
Physical condition: ECOG score 0-2;
Obtained informed consent signed by the patient or family.

Who cannot join

Allergy or significant contraindication to any of the drugs involved in the protocol;
Patients with concomitant myelofibrosis;
Severe cardiac disease, including myocardial infarction and cardiac insufficiency;
Concomitant malignant tumours of other organs;
Patients with active tuberculosis and HIV-positive patients;
Other blood system diseases at the same time;

Show all 11Show fewer

Pregnant or breastfeeding women;
Inability to understand or comply with the study protocol;
Previous intolerance or allergy to similar drugs;
Concurrent participation in other clinical studies;
Any other condition that prevents the study from proceeding.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Fuling Zhou, Doctor contact

027-67813137

zhoufuling@whu.edu.cn

City, postcode or hospital

Sites recruiting now only

11 sites in 1 country

China11 sites, 11 recruiting

The Central Hospital of Huanggang
Huanggang, Hubei, 438000
Not yet recruiting
The First People's Hospital of Jingzhou
Jingzhou, Hubei, 434000
Not yet recruiting
Jingzhou Central Hospital
Jingzhou, Hubei, 434020
Not yet recruiting
Shiyan Taihe Hospital
Shiyan, Hubei, 442000
Not yet recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030009
Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Zhou Fuling, director, +86-02767813137, zhoufuling@163.com
Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Wuxi, Jiangsu, 214028
Not yet recruiting
Xianning Central Hospital
Xianning, Hubei, 437100
Not yet recruiting
The Central Hospital of Xiaogan
Xiaogan, Hubei, 432100
Not yet recruiting
Yichang Central Hospital
Yichang, Hubei, 443003
Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Not yet recruiting

Other trials in China

About this study

Official title: A Prospective, Multicenter, Randomized Controlled Study on the MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

Read the detailed description

In this study, AML patients were randomly divided into MA+AZA treatment group and DA+AZA treatment group by conducting a prospective, multicentre, exploratory, randomised controlled study. By observing the efficacy and safety of the MA+AZA combination regimen in the treatment of primary AML, and comparing the superiority of the traditional regimen, high-quality clinical evidence was obtained, providing practical evidence to support the improvement of the intervention effect and clinical prognosis of primary AML.

Conditions: Acute Myeloid Leukaemia
Being tested: mitoxantrone liposome, Ara-Cytarabine and azacitidine, Daunorubicin,Ara-Cytarabine, azacitidine
Keywords: Mitoxantrone liposome, Newly diagnosed AML patients, Ara-Cytarabine, Azacytidine
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.

mitoxantrone liposome, Ara-Cytarabine and azacitidineDrug
Mitoxantrone hydrochloride liposome 24 mg/m2, IV every 4 weeks, day 1; Ara-Cytarabine 100 mg/m2, IV every 12 h, days 1-7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7
Daunorubicin,Ara-Cytarabine, azacitidineDrug
Daunorubicin 60 mg/m2, intravenously, once daily, days 1 to 3; Ara-Cytarabine 100 mg/m2, IV drip, every 12h, days 1 to 7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7;

Study groups in NCT06345365
Study group	Role	What they receive
mitoxantrone liposome, Ara-Cytarabine and azacitidine	Experimental	Mitoxantrone hydrochloride liposome 24 mg/m2, IV every 4 weeks, day 1; Ara-Cytarabine 100 mg/m2, IV every 12 h, days 1-7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7; Receives: Drug: mitoxantrone liposome, Ara-Cytarabine and azacitidine
Daunorubicin, Ara-Cytarabine and azacitidine	Active comparator	Daunorubicin 60 mg/m2, intravenously, once daily, days 1 to 3 Ara-Cytarabine 100 mg/m2, IV drip, every 12h, days 1 to 7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7; Receives: Drug: Daunorubicin,Ara-Cytarabine, azacitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

Complete remission rate
Bone marrow primitive cells <5%, no primitive cells with Auer vesicles, no primitive cells in the peripheral blood, no extramedullary leukaemia, neutrophil count ≥1.0×109/L, platelet count ≥100×109/L.
Measured: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)

Secondary outcomes (8)

Incidence of adverse events
Incidence of adverse events, e.g., GI adverse reactions, cardiotoxicity, etc.
Measured: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Compound CR rate
CR+ CRi
Measured: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Objective remission rate
CR+CRi+MLFS+PR
Measured: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
No remission rate
Patients not meeting criteria for CR, CRi, MLFS or PR
Measured: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Event-free survival
From the date of the patient's first dose to the date of treatment failure,haematological relapse after CR/CRi or all-cause mortality, whichever occurs first
Measured: Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any caus)
Disease-free survival
For patients achieving CR or CRi only, from the date of achieving remission to the date of relapse or death from any cause
Measured: From date of achieving remission to date of relapse or death from any cause (Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any cause, whichever comes first)
Overall survival
The time from the patient's first dose of medication to the time of death from any cause.
Measured: Time from the patient's first dose of medication to death from any cause (Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any cause, whichever comes first)
Mortality rate
Early deaths: all-cause deaths within the timeframe associated with study treatment (e.g., 30 days, 60 days after starting treatment); Cumulative deaths: deaths within the period from the date of achieving remission to the date of no prior relapse for patients achieving CR or CRi only.
Measured: 30 days, 60 days after starting treatment; Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any cause, whichever comes first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jan 202431 Dec 2028

First posted3 Apr 2024
Study start18 Jan 2024
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Myeloid LeukaemiaStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 154 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06345365
Sponsor's protocol ID: 09
Status last verified: Jan 2024
First submitted: 1 Feb 2024
Last updated: 10 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Fuling Zhou, Doctor

027-67813137

zhoufuling@whu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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

All Acute Myeloid Leukaemia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Randomized Controlled Study on the MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
ClinicalTrials.gov ID: NCT06345365
Acronym / sponsor ID: 09
Conditions: Acute Myeloid Leukaemia
Keywords: Mitoxantrone liposome, Newly diagnosed AML patients, Ara-Cytarabine, Azacytidine
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 154 participants (estimated)
Lead sponsor: Zhongnan HospitalUniversity, hospital or other
Collaborators: Ruijin Hospital, Shanxi Province Cancer Hospital, The First Affiliated Hospital of Zhengzhou University, Jingzhou Central Hospital, Yichang Central People's Hospital, Taihe Hospital, Central Hospital of Xiaogan, Xianning Central Hospital, The First People's Hospital of Jingzhou
Study start: 18 Jan 2024 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 3 Apr 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
mitoxantrone liposome, Ara-Cytarabine and azacitidine	Experimental	Drug: mitoxantrone liposome, Ara-Cytarabine and azacitidineMitoxantrone hydrochloride liposome 24 mg/m2, IV every 4 weeks, day 1; Ara-Cytarabine 100 mg/m2, IV every 12 h, days 1-7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7;
Daunorubicin, Ara-Cytarabine and azacitidine	Active comparator	Drug: Daunorubicin,Ara-Cytarabine, azacitidineDaunorubicin 60 mg/m2, intravenously, once daily, days 1 to 3 Ara-Cytarabine 100 mg/m2, IV drip, every 12h, days 1 to 7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7;

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients with primary AML with morphologically and immunologically confirmed diagnosis of bone marrow;
Age 18-75 years old;
Liver and renal function: serum total bilirubin ≤1.5 × upper limit of normal (ULN), AST/ALT <2 × ULN, serum creatinine <1.5 × ULN, 80 ml/min ≤ creatinine clearance ≤120 ml/min;
Cardiac function: ejection fraction EF ≥50%, ultrasensitive troponin and natriuretic peptide <1.5 × ULN;
Physical condition: ECOG score 0-2;

Key exclusion criteria (11 listed)

Allergy or significant contraindication to any of the drugs involved in the protocol;
Patients with concomitant myelofibrosis;
Severe cardiac disease, including myocardial infarction and cardiac insufficiency;
Concomitant malignant tumours of other organs;
Patients with active tuberculosis and HIV-positive patients;

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 liposome, Ara-Cytarabine and azacitidineMitoxantrone hydrochloride liposome 24 mg/m2, IV every 4 weeks, day 1; Ara-Cytarabine 100 mg/m2, IV every 12 h, days 1-7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7	Drug	mitoxantrone liposome, Ara-Cytarabine and azacitidine
Daunorubicin,Ara-Cytarabine, azacitidineDaunorubicin 60 mg/m2, intravenously, once daily, days 1 to 3; Ara-Cytarabine 100 mg/m2, IV drip, every 12h, days 1 to 7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7;	Drug	Daunorubicin, Ara-Cytarabine and azacitidine

Primary outcome

Complete remission rate
Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Bone marrow primitive cells <5%, no primitive cells with Auer vesicles, no primitive cells in the peripheral blood, no extramedullary leukaemia, neutrophil count ≥1.0×109/L, platelet count ≥100×109/L.

8 secondary outcomes

Incidence of adverse events
Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Compound CR rate
Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Objective remission rate
Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
No remission rate
Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Event-free survival
Time frame: Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any caus)
Disease-free survival
Time frame: From date of achieving remission to date of relapse or death from any cause (Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any cause, whichever comes first)
Overall survival
Time frame: Time from the patient's first dose of medication to death from any cause (Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any cause, whichever comes first)
Mortality rate
Time frame: 30 days, 60 days after starting treatment; Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any cause, whichever comes first

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 10 Apr 2024.
Individual participant dataSharing planned: No

Related trials for Acute Myeloid Leukaemia

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.

Fuling Zhou, Doctor contact

027-67813137

zhoufuling@whu.edu.cn

Fuling Zhou study director

Wuhan University

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 11 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 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Fuling Zhou, Doctor (027-67813137, zhoufuling@whu.edu.cn), 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: Efficacy evaluation at 2-3 weeks after the first cycle (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?

On the ClinicalTrials.gov record for NCT06345365.

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 10 Apr 2024.