Relapsed/Refractory Acute Myeloid LeukaemiaPhase 2NCT06434662
Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R/R AML
A Phase 2 study testing mitoxantrone hydrochloride liposome, Cytarabine and Venetoclax in people with Relapsed/Refractory Acute Myeloid Leukaemia and Myeloid Malignancy, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
The goal of this study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Acute Myeloid Leukaemia, Myeloid Malignancy
- What is being tested?
- mitoxantrone hydrochloride liposome, Cytarabine and Venetoclax
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 29 Feb 2024to Jun 2026
- Phase
- Phase 2
- 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 years and older
- 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.
- Age ≥18.
- Clinically diagnosed relapsed/refractory AML, excluding acute promyelocytic leukemia.
- Initial treatment patients who failed after 2 courses of treatment with standard regimen.
- Bone marrow blasts≥5% after the first CR/CRi, or reappearance of blasts in the blood in at least 2 peripheral blood samples at least one week apart, or leukemia cell infiltration appeared in extramedullary without treatment.
- First conversion from MRD negativity to MRD positivity without treatment.
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- Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2.
- Researchers determined that the patients could tolerate intensive chemotherapy.
- Life expectancy > 3 months.
- AST/ALT≤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
- Previous anti-tumor therapy meets one of the following criteria:
- Prior therapy with mitoxantrone or mitoxantrone liposome;
- Prior therapy with doxorubicin or 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);
- Have received other anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, Chinese medicines with anti-tumor activity, except those that do not affect the efficacy of the study as determined by the investigator) or participated in other clinical trials and received clinical trial drugs within 4 weeks or 5 half-lives of the drug before the study;
- Cardiovascular diseases, including but not limited to:
- QTc interval >480 ms or long QTc syndrome in screening;
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- Complete left bundle branch block, 2 or 3 grade atrioventricular block;
- Requiring treatment of serious and uncontrolled arrhythmia;
- New York Heart Association（NYHA≥3;
- 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.
- Central nervous system leukemia;
- 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).
- Subjects are suffering from any other uncontrollable disease (including but not limited to: uncontrolled diabetes and hypertension, and advanced infection);
- HIV infection.
- HBsAg or HBcAb positive, with HBV-DNA≥1x10^3 copies/mL; or HCV-RNA≥1x10^3 copies/mL;
- A history of immediate or delayed allergy to similar drug and excipients of the investigate drug.
- Pregnant, lactating female or subjects who refuse to use effective contraception during the study.
- 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.
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
About this study
Official title: A Phase II Study of the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection, Cytarabine and Venetoclax in Patients With Relapsed/Refractory AML
The goal of this study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. It will also tentatively explore the correlation between different biological characteristics and therapeutic efficacy. The main questions it aims to answer are:Dose the combination regimen of MAV enhanced the composite complete remission in R/R AML? Participants will receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.
Read the detailed description
Acute myeloid leukemia (AML) is a highly aggressive hematologic malignancy with a poor prognosis. The "3+7" regimen, combining anthracyclines with cytarabine, remains the standard treatment for first line treatment. However, about 20% of patients will develop into primary refractory disease, and more than 50% of patients who achieved complete remission will eventually relapse. For patients with R/R AML, there is currently no established standard treatment. Combining the third drugs with "3+7" regimen is one of the clinical exploration directions.
The purpose of this prospective, single-center, single-arm, pahse II study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax in the treatment of R/R AML. All participants will receive MAV treatment including 24 mg/m2 mitoxantrone hydrochloride liposome on day 1, 1.0 g/m2 q12h cytarabine on day 1,3,5 and 400 mg venetoclax on day 2-10 with a dose escalation on day 2-4. Each cycle consists of 4 weeks. A maximum of 2 cycles of therapy are planned.
- 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 (1.0 g/m^2, q12h ) on day 1,3,5, 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 |
|---|---|---|
| MAV regimen | Experimental | mitoxantrone hydrochloride liposome injection, cytarabine combined with venetoclax 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.
Composite complete remission (CRc) rate
Blast rate lower than 5% with or without peripheral blood cell recover
Measured: At the end of each cycle (each cycle is 28 days), up to 2 cycles
Secondary outcomes (6)
Overall response rate (ORR)
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 12 months
Event free survival (EFS)
Defined for all patients in a trial; 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 12 months
overall survival (OS)
Defined for all patients in a trial; measured from day 1 of treatment to the date of death from any cause;
Measured: up to 12 months
Rate of CR without minimal residual disease (CR MRD-)
Percentage of participants who achieve a CR MRD- as defined by investigators based on ELN 2022 criteria; MRD level is detected by flow cytometry which value <0.1% is defined as negtive;
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 drug was evaluated by NCI-CTC AE 5.0 standard.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 posted30 May 2024
- Study start29 Feb 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Acute Myeloid LeukaemiaStudies 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Jin, M.D., Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434662
- Sponsor's protocol ID
- CSPC-DED-AML-K13
- Status last verified
- Mar 2024
- First submitted
- 10 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection, Cytarabine and Venetoclax in Patients With Relapsed/Refractory AML
- ClinicalTrials.gov ID
- NCT06434662
- Acronym / sponsor ID
- CSPC-DED-AML-K13
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 30 May 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 goal of this study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. It will also tentatively explore the correlation between different biological characteristics and therapeutic efficacy. The main questions it aims to answer are:Dose the combination regimen of MAV enhanced the composite complete remission in R/R AML? Participants will receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.
Detailed description
Acute myeloid leukemia (AML) is a highly aggressive hematologic malignancy with a poor prognosis. The "3+7" regimen, combining anthracyclines with cytarabine, remains the standard treatment for first line treatment. However, about 20% of patients will develop into primary refractory disease, and more than 50% of patients who achieved complete remission will eventually relapse. For patients with R/R AML, there is currently no established standard treatment. Combining the third drugs with "3+7" regimen is one of the clinical exploration directions.
The purpose of this prospective, single-center, single-arm, pahse II study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax in the treatment of R/R AML. All participants will receive MAV treatment including 24 mg/m2 mitoxantrone hydrochloride liposome on day 1, 1.0 g/m2 q12h cytarabine on day 1,3,5 and 400 mg venetoclax on day 2-10 with a dose escalation on day 2-4. Each cycle consists of 4 weeks. A maximum of 2 cycles of therapy are planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAV regimen | Experimental | Drug: mitoxantrone hydrochloride liposome, Drug: Cytarabine, Drug: Venetoclaxmitoxantrone hydrochloride liposome injection, cytarabine combined with venetoclax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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.
- Age ≥18.
- Clinically diagnosed relapsed/refractory AML, excluding acute promyelocytic leukemia.
- Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2.
- Researchers determined that the patients could tolerate intensive chemotherapy.
Key exclusion criteria (20 listed)
- Previous anti-tumor therapy meets one of the following criteria:
- Cardiovascular diseases, including but not limited to:
- Central nervous system leukemia;
- 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).
- Subjects are suffering from any other uncontrollable disease (including but not limited to: uncontrolled diabetes and hypertension, and advanced infection);
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 | MAV regimen |
| CytarabineCytarabine (1.0 g/m^2, q12h ) on day 1,3,5, every 4 weeks | Drug | MAV regimen |
| VenetoclaxVenetoclax 100 mg on day 2，200 mg on day 3，400 mg on day 4-10, every 4 weeks | Drug | MAV regimen |
Primary outcome
Composite complete remission (CRc) rate
Time frame: At the end of each cycle (each cycle is 28 days), up to 2 cycles
Blast rate lower than 5% with or without peripheral blood cell recover
6 secondary outcomes
Overall response rate (ORR)
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 12 months
Event free survival (EFS)
Time frame: up to 12 months
overall survival (OS)
Time frame: up to 12 months
Rate of CR without minimal residual disease (CR MRD-)
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
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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.
Jie Jin, M.D. principal investigator
Zhejiang University
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 Relapsed/Refractory Acute Myeloid Leukaemia and Myeloid Malignancy, 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 10 inclusion and 20 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 30 May 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?
Results are not available in the source record.
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?
Composite complete remission (CRc) rate (time frame: At the end of each cycle (each cycle is 28 days), up to 2 cycles). 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 30 May 2024.