Acute Myeloid LeukemiaPhase 2NCT06621199
Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML
A Phase 2 study testing Mitoxantrone hydrochloride liposome, Cytarabine and Venetoclax in people with Acute Myeloid Leukemia, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This is a phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML. To account, conservatively, for a 10% dropout rate before study completion, we planned to include 42 patients. Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Mitoxantrone hydrochloride liposome, Cytarabine and Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 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 60 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Aged 60-70 years (including boundary values 60 and 70);
- Newly diagnosed primary AML according to the WHO 2022 classification.
- Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2.
- Life expectancy ≥ 3 months.
- ALT/AST≤2.5 ULN (for subjects with hepatic infiltration≤5 ULN); Total bilirubin≤1.5 ULN (for subjects with hepatic infiltration≤3 ULN); Serum creatinine≤1.5 ULN.
Who cannot join
- Subjects meet any of the following conditions:
- Acute promyelocytic leukemia;
- Secondary AML caused by chemotherapy and/or radiotherapy to treat solid tumor or antecedent hematological disorders such as MDS, MPN, MDS/MPN;
- AML following blast transformation of prior chronic myeloid leukemia;
- Central nervous system (CNS) leukemia;
- Subjects with malignant tumors (excluding cured skin basal cell carcinoma, cervical carcinoma in situ, and other malignant tumors that have not been treated and effectively controlled within the past 5 years) within the past 5 years.
Show all 22Show fewer
- Subjects who have received anthracycline pretreatment or other anti-AML treatments (except for hydroxyurea, leukapheresis and other leukocyte-lowering treatments);
- Subjects who received strong or moderate CYP3A inducers/inhibitors or P-glycoprotein (P-gp) inhibitors within 7 days before starting study treatment;
- Subjects who are unable to take oral medications or have malabsorption syndrome;
- Cardiac function and disease conform to one of the following conditions:
- Long QTc syndrome or QTc interval >480 ms;
- Complete left bundle branch block, degree II or III atrioventricular block;
- Severe, uncontrolled arrhythmia requiring medical treatment;
- New York Heart Association(NYHA) classification ≥ grade II;
- Cardiac ejection fraction (EF) was less than 50%;
- A history of myocardial infarction, unstable angina pectoris, severely unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically severe pericardial disease, or electrocardiogram evidence of acute ischemic or active conduction abnormalities within 6 months prior to enrollment;
- Uncontrolled systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.);
- Human immunodeficiency virus (HIV) infection (HIV antibody positive);
- HBsAg or HBcAb positive, with HBV-DNA≥1x10^3 copies/mL; HCV Ab positive, with HCV-RNA≥1x10^3 copies/mL;
- A history of immediate or delayed allergy to similar drug and excipients of the investigate drug.
- With a history of severe neurological or psychiatric illness.
- Not suitable for this study as decided 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
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Jie Jin, M.D., +86 571-87236896, jiej0503@163.com
Huafeng Wang, M.D., 1509036@zju.edu.cn
About this study
Official title: A Prospective, Single-arm, Multi-center, Phase 2 Clinical Study of Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML
This is a phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML. To account, conservatively, for a 10% dropout rate before study completion, we planned to include 42 patients. The primary endpoint is 2-year event free survival(EFS).
Read the detailed description
The optimal induction chemotherapy regimen for newly diagnosed elderly AML patients who are eligible for intense chemotherapy is currently not well defined. Mitoxantrone hydrochloride liposome (Lipo-MIT) is an innovative anthracycline nano-drug, which has been demonstrated favorable pharmacokinetic characteristics, high cardiac safety, and shown preliminary efficacy in adult AML. Thus, we designed a prospective, single-arm, phase 2 trial to explore the efficacy and safety of Lipo-MIT in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML.
The induction therapy is a combination of Lipo-MIT (24 mg/m^2, day 1), cytarabine(100mg/m^2, day 1-5) and venetoclax (200mg day 2, 300mg day 3, 400mg day 4-10,), and would be applied for two cycles. Patients who achieve CR/CRi after using MAV induction regimen will receive the consolidation therapy according to the patients' cytogenetic-molecular risk stratification and maintenance therapy. After completion of the treatment phase, patients entered the follow-up period.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Mitoxantrone hydrochloride liposome, Cytarabine, Venetoclax
- 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 hydrochloride liposomeDrug
Mitoxantrone hydrochloride liposome 24 mg/m^2 on day 1, every 4 weeks
CytarabineDrug
Cytarabine 100 mg/m^2 on day 1-5, every 4 weeks
VenetoclaxDrug
Venetoclax 100 mg on day 2，200 mg on day 3，400 mg on day 4-10, every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Modified MAV regimen | Experimental | Mitoxantrone hydrochloride liposome ×1 day, cytarabine × 5 days combined with venetoclax as induction regimen Receives: Drug: Mitoxantrone hydrochloride liposome; Drug: Cytarabine; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year event-free survival (EFS) rate
Defined for all patients in the study. Measured from day 1 of treatment to the date of treatment failure, hematologic relapse from CR/CRi or death from any cause, whichever occurs first.
Measured: up to 2 years
Secondary outcomes (6)
Composite complete remission (CRc) rate of induction therapy
Complete remission plus complete remission with incomplete hematologic recovery (CR+CRi). Response is assessed according to the the European LeukemiaNet (ELN) 2022 criteria.
Measured: At the end of each cycle (each cycle is 28 days), up to 2 cycles
Overall response rate (ORR) of induction therapy
CR+CRi+morphologic leukemia-free state+partial remission (CR+CRi+MLFS+PR). Response is assessed according to the the European LeukemiaNet (ELN) 2022 criteria.
Measured: At the end of each cycle (each cycle is 28 days), up to 2 cycles
Relapsed-free survival (RFS)
Defined only for patients achieving CR or CRi. Measured from the date of achievement of remission until the date of hematologic relapse or death from any cause.
Measured: up to 2 years
Overall survival (OS)
Defined for all patients in the study. Measured from day 1 of treatment to the date of death from any cause.
Measured: up to 2 years
Rate of CR/CRi without measurable residual disease after induction therapy
Percentage of participants who achieve a CR MRD-/CRi MRD- as defined by investigators based on ELN 2022 criteria. MRD level is detected by flow cytometry and negtive MRD is defined as MRD value <0.1%.
Measured: At the end of each cycle (each cycle is 28 days), up to 2 cycles
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The safety of the regimen was evaluated by NCI-CTC AE 5.0 standard which including hematologic and non-hematologic toxicity.
Measured: From day 1 of treatment to 28 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start8 Jul 2024
- Primary completion31 Dec 2027 (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 Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621199
- Sponsor's protocol ID
- CSPC-DED-AML-K15
- Status last verified
- Jul 2024
- First submitted
- 29 Sep 2024
- Last updated
- 1 Oct 2024
- 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 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multi-center, Phase 2 Clinical Study of Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML
- ClinicalTrials.gov ID
- NCT06621199
- Acronym / sponsor ID
- CSPC-DED-AML-K15
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Oct 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.
This is a phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML. To account, conservatively, for a 10% dropout rate before study completion, we planned to include 42 patients. The primary endpoint is 2-year event free survival(EFS).
Detailed description
The optimal induction chemotherapy regimen for newly diagnosed elderly AML patients who are eligible for intense chemotherapy is currently not well defined. Mitoxantrone hydrochloride liposome (Lipo-MIT) is an innovative anthracycline nano-drug, which has been demonstrated favorable pharmacokinetic characteristics, high cardiac safety, and shown preliminary efficacy in adult AML. Thus, we designed a prospective, single-arm, phase 2 trial to explore the efficacy and safety of Lipo-MIT in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML.
The induction therapy is a combination of Lipo-MIT (24 mg/m^2, day 1), cytarabine(100mg/m^2, day 1-5) and venetoclax (200mg day 2, 300mg day 3, 400mg day 4-10,), and would be applied for two cycles. Patients who achieve CR/CRi after using MAV induction regimen will receive the consolidation therapy according to the patients' cytogenetic-molecular risk stratification and maintenance therapy. After completion of the treatment phase, patients entered the follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified MAV regimen | Experimental | Drug: Mitoxantrone hydrochloride liposome, Drug: Cytarabine, Drug: VenetoclaxMitoxantrone hydrochloride liposome ×1 day, cytarabine × 5 days combined with venetoclax as induction regimen |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Aged 60-70 years (including boundary values 60 and 70);
- Newly diagnosed primary AML according to the WHO 2022 classification.
- Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2.
- Life expectancy ≥ 3 months.
Key exclusion criteria (22 listed)
- Subjects meet any of the following conditions:
- Subjects with malignant tumors (excluding cured skin basal cell carcinoma, cervical carcinoma in situ, and other malignant tumors that have not been treated and effectively controlled within the past 5 years) within the past 5 years.
- Subjects who have received anthracycline pretreatment or other anti-AML treatments (except for hydroxyurea, leukapheresis and other leukocyte-lowering treatments);
- Subjects who received strong or moderate CYP3A inducers/inhibitors or P-glycoprotein (P-gp) inhibitors within 7 days before starting study treatment;
- Subjects who are unable to take oral medications or have malabsorption syndrome;
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 liposomeMitoxantrone hydrochloride liposome 24 mg/m^2 on day 1, every 4 weeks | Drug | Modified MAV regimen |
| CytarabineCytarabine 100 mg/m^2 on day 1-5, every 4 weeks | Drug | Modified MAV regimen |
| VenetoclaxVenetoclax 100 mg on day 2，200 mg on day 3，400 mg on day 4-10, every 4 weeks | Drug | Modified MAV regimen |
Primary outcome
2-year event-free survival (EFS) rate
Time frame: up to 2 years
Defined for all patients in the study. Measured from day 1 of treatment to the date of treatment failure, hematologic relapse from CR/CRi or death from any cause, whichever occurs first.
6 secondary outcomes
Composite complete remission (CRc) rate of induction therapy
Time frame: At the end of each cycle (each cycle is 28 days), up to 2 cycles
Overall response rate (ORR) of induction therapy
Time frame: At the end of each cycle (each cycle is 28 days), up to 2 cycles
Relapsed-free survival (RFS)
Time frame: up to 2 years
Overall survival (OS)
Time frame: up to 2 years
Rate of CR/CRi without measurable residual disease after induction therapy
Time frame: At the end of each cycle (each cycle is 28 days), up to 2 cycles
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From day 1 of treatment to 28 days after the last dose
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 1 Oct 2024.
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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.
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 Mitoxantrone hydrochloride liposome, Cytarabine and Venetoclax in people with Acute Myeloid Leukemia, run by First Affiliated Hospital of Zhejiang University 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 6 inclusion and 22 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 1 Oct 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 Jie Jin, M.D. (+86 571-87236896, jiej0503@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year event-free survival (EFS) rate (time frame: up to 2 years). 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 1 Oct 2024.