High-risk (Secondary) Acute Myeloid LeukemiaPhase 3NCT06182592
A Bridging Study of Liposomal Cytarabine-Daunorubicin in Treating Olderly Patients With Treatment-naive High-Risk (Secondary) Acute Myeloid Leukemia
A Phase 3 study testing Liposomal cytarabine-daunorubicin for injection and 7+3 (cytarabine and daunorubicin) in people with High-risk (Secondary) Acute Myeloid Leukemia, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.
Trial summary
The purpose of this bridging study is to determine the efficacy of liposomal cytarabine-daunorubicin for injection compared with cytarabine and daunorubicin in older patients with high-risk (secondary) acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- High-risk (Secondary) Acute Myeloid Leukemia
- What is being tested?
- Liposomal cytarabine-daunorubicin for injection and 7+3 (cytarabine and daunorubicin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jan 2024to Aug 2026
- Phase
- Phase 3
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand the study and voluntarily sign informed consent.
- Male or female between 60-75 years of age (inclusive).
- Pathological diagnosis of AML according to 2022 WHO criteria (with at least 20% blasts in the peripheral blood or bone marrow) and fulfill of one of the following standards:
- Therapy related AML: t-AML must have a documented history of prior cytotoxic therapy or ionizing radiotherapy for an unrelated disease;
- AML with a history of myelodysplasia: MDSAML must have bone marrow documentation of prior MDS;
- AML with a history of CMMoL: CMMoLAML must have bone marrow documentation of prior CMMoL;
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- De novo AML with karyotypic abnormalities characteristic of MDS: de novoAML must have cytogenetics with abnormalities per WHO.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Laboratory values meet the following criteria:
- Serum creatinine≤2 × ULN;
- Serum total bilirubin≤2 × ULN, ≤3 × ULN for patients with liver involvement;
- Serum alanine aminotransferase or aspartate aminotransferase≤3 × ULN, ≤5 × ULN for patients with liver involvement.
- Cardiac function (LVEF) ≥ 50% by echocardiography or MUGA.
- QTcF (Fridericia's) for male<450 ms, for female<470 ms at screening.
- Male and female of childbearing potential must agree to use contraceptive measures (such as IUD, contraceptive or condom) during the study and within 6 months after the end of the study.
Who cannot join
- Acute promyelocytic leukemia; or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization.
- Except for CMMoL, patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible.
- History of other malignancy within 3 years before randomization, expect for cancers that have been cured (basal cell or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of cervix and breast or prostate cancer with Gleason score of 6).
- Patients with clinical evidence of active CNS leukemia.
- Prior treatment for AML (except for hydroxyurea) or stem-cell transplantation.
- Administration of any therapy for MDS (conventional or investigational) within 2 weeks prior to of the first dose of study drug; use of hydroxyurea for the purpose of inhibiting rapid tumor proliferation within 24 hours before the first dose. Toxicities associated with prior MDS therapy have not recovered to grade 1 or less prior to start of treatment.
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- Any major surgery or radiation therapy within 4 weeks.
- Patients with previous cumulative exposure to anthracyclines >368 mg/m^2 daunorubicin (or equivalent drug equivalent dose level).
- Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent.
- Patients with myocardial impairment of any cause (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by NYHA Criteria (Class Ш or Ⅳ staging).
- Active or uncontrolled infection.
- Current evidence of invasive fungal infection (blood or tissue culture).
- Patients with known HIV, hepatitis B or hepatitis C infection.
- Patients who are hypersensitive to cytarabine, daunorubicin or liposomal products.
- Patients with a history of Wilson's disease or other copper-metabolism disorders.
- Participation in another clinical trial or treatment with any investigational drug within 28 days prior to screening.
- Any patients whom the investigator believes will not be a good candidate for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences
Tianjin
Jianxiang Wang, MD, 86-022-23909120, wangjx@ihcams.ac.cn
About this study
Official title: A Randomized, Multi-center, Open-label Phase III Bridging Study to Compare Efficacy of Liposomal Cytarabine-Daunorubicin for Injection With Cytarabine and Daunorubicin in Treating Older Patients With High-Risk (Secondary) Acute Myeloid Leukemia
The purpose of this bridging study is to determine the efficacy of liposomal cytarabine-daunorubicin for injection compared with cytarabine and daunorubicin in older patients with high-risk (secondary) acute myeloid leukemia.
Read the detailed description
Liposomal cytarabine-daunorubicin for injection manufactured by CSPC Zhongnuo Pharmaceutical Technology Co., Ltd is a class 3 chemical drug imitating Vyxeos developed by Jazz Pharmaceuticals plc. This bridging trial compares the efficacy of liposomal cytarabine-daunorubicin for injection manufactured by CSPC Zhongnuo Pharmaceutical Technology Co., Ltd with cytarabine/daunorubicin (7+3) in elderly patients with treatment-naïve high-risk (secondary) AML to determine that test drug is comparable to Vyxeos in efficacy, safety and pharmacokinetic properties. Patients will be randomized in a 1:1 ratio to receive liposomal cytarabine-daunorubicin or daunorubicin/cytarabine as induction and consolidation chemotherapy. Patients will receive up to two cycles of induction and consolidation therapy. After the treatment period, there is a follow-up phase for overall survival.
- Being tested
- Liposomal cytarabine-daunorubicin for injection, 7+3 (cytarabine and daunorubicin)
- Medical subject headings
- Neoplasm Metastasis, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal cytarabine-daunorubicin for injectionDrug
First induction: 100 units/m^2 by 90-minute IV infusion on Days 1, 3, 5. Second induction: 100 units/m^2 by 90-minute IV infusion on Days 1 and 3. Consolidation therapy: 65 units/m^2 by 90-minute IV infusion on Days 1 and 3.
7+3 (cytarabine and daunorubicin)Drug
First induction: 7+3 will be administered as: cytarabine at a dose of 100 mg/m^2/day on Days 1 through 7 by continuous infusion, and daunorubicin at a dose of 60 mg/m^2/day on Days 1, 2, and 3.
Second induction: 5+2 will be administered as: cytarabine at a dose of 100 mg/m^2/day on Days 1 through 5 by continuous infusion and daunorubicin at a dose of 60 mg/m^2/day on Days 1 and 2.
Consolidation therapy: 5+2 will be administered as: cytarabine at a dose of 100 mg/m^2/day on Days 1 through 5 by continuous infusion, and daunorubicin at a dose of 60 mg/m^2/day on Days 1 and 2.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (liposomal cytarabine-daunorubicin for injection) | Experimental | Patients are eligible to receive up to 2 inductions and up to 2 consolidations with liposomal cytarabine-daunorubicin for injection. The number of inductions and consolidations a patient received will depend on response. Receives: Drug: Liposomal cytarabine-daunorubicin for injection |
| Arm B (7+3) | Experimental | Patients are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7+3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received will depend on response. Receives: Drug: 7+3 (cytarabine and daunorubicin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival will be measured from the date of randomization to death from any cause.
Measured: Up to 2 years
Secondary outcomes (6)
Event-free survival (EFS)
EFS is defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from complete remission (CR) or complete remission with incomplete count recovery (CRi) or death from any cause, whichever occurs first.
Measured: Up to 2 years
Duration of remission (DoR)
DoR is defined as the time from the day achieving CR or CRi to the date of relapse or death. Only patients achieving CR or CRi will be assessed for remission duration.
Measured: Up to 2 years
CR rate
Proportion of patients with complete remission during the treatment period.
Measured: Up to 2 years
Composite remission rate
Proportion of patients with CR or CRi.
Measured: Up to 2 years
Proportion of patients receiving a haematopoietic stem cell transplant (HSCT)
The number and percentage of patient transferred for HSCT after induction treatment will be recorded.
Measured: Up to 2 years
Proportion of pateints who achieve CR with MRD negativity
The number and percentage of patients who are MRD negative.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk (Secondary) Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182592
- Sponsor's protocol ID
- HC1702-004
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center, Open-label Phase III Bridging Study to Compare Efficacy of Liposomal Cytarabine-Daunorubicin for Injection With Cytarabine and Daunorubicin in Treating Older Patients With High-Risk (Secondary) Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06182592
- Acronym / sponsor ID
- HC1702-004
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 27 Dec 2023 (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 purpose of this bridging study is to determine the efficacy of liposomal cytarabine-daunorubicin for injection compared with cytarabine and daunorubicin in older patients with high-risk (secondary) acute myeloid leukemia.
Detailed description
Liposomal cytarabine-daunorubicin for injection manufactured by CSPC Zhongnuo Pharmaceutical Technology Co., Ltd is a class 3 chemical drug imitating Vyxeos developed by Jazz Pharmaceuticals plc. This bridging trial compares the efficacy of liposomal cytarabine-daunorubicin for injection manufactured by CSPC Zhongnuo Pharmaceutical Technology Co., Ltd with cytarabine/daunorubicin (7+3) in elderly patients with treatment-naïve high-risk (secondary) AML to determine that test drug is comparable to Vyxeos in efficacy, safety and pharmacokinetic properties. Patients will be randomized in a 1:1 ratio to receive liposomal cytarabine-daunorubicin or daunorubicin/cytarabine as induction and consolidation chemotherapy. Patients will receive up to two cycles of induction and consolidation therapy. After the treatment period, there is a follow-up phase for overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (liposomal cytarabine-daunorubicin for injection) | Experimental | Drug: Liposomal cytarabine-daunorubicin for injectionPatients are eligible to receive up to 2 inductions and up to 2 consolidations with liposomal cytarabine-daunorubicin for injection. The number of inductions and consolidations a patient received will depend on response. |
| Arm B (7+3) | Experimental | Drug: 7+3 (cytarabine and daunorubicin)Patients are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7+3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received will depend on response. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Able to understand the study and voluntarily sign informed consent.
- Male or female between 60-75 years of age (inclusive).
- Pathological diagnosis of AML according to 2022 WHO criteria (with at least 20% blasts in the peripheral blood or bone marrow) and fulfill of one of the following standards:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Laboratory values meet the following criteria:
Key exclusion criteria (17 listed)
- Acute promyelocytic leukemia; or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization.
- Except for CMMoL, patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible.
- History of other malignancy within 3 years before randomization, expect for cancers that have been cured (basal cell or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of cervix and breast or prostate cancer with Gleason score of 6).
- Patients with clinical evidence of active CNS leukemia.
- Prior treatment for AML (except for hydroxyurea) or stem-cell transplantation.
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 |
|---|---|---|
| Liposomal cytarabine-daunorubicin for injectionFirst induction: 100 units/m^2 by 90-minute IV infusion on Days 1, 3, 5. Second induction: 100 units/m^2 by 90-minute IV infusion on Days 1 and 3. Consolidation therapy: 65 units/m^2 by 90-minute IV infusion on Days 1 and 3. | Drug | Arm A (liposomal cytarabine-daunorubicin for injection) |
| 7+3 (cytarabine and daunorubicin)First induction: 7+3 will be administered as: cytarabine at a dose of 100 mg/m^2/day on Days 1 through 7 by continuous infusion, and daunorubicin at a dose of 60 mg/m^2/day on Days 1, 2, and 3. Second induction: 5+2 will be administered as: cytarabine at a dose of 100 mg/m^2/day on Days 1 through 5 by continuous infusion and daunorubicin at a dose of 60 mg/m^2/day on Days 1 and 2. Consolidation therapy: 5+2 will be administered as: cytarabine at a dose of 100 mg/m^2/day on Days 1 through 5 by continuous infusion, and daunorubicin at a dose of 60 mg/m^2/day on Days 1 and 2. | Drug | Arm B (7+3) |
Primary outcome
Overall Survival (OS)
Time frame: Up to 2 years
Overall survival will be measured from the date of randomization to death from any cause.
6 secondary outcomes
Event-free survival (EFS)
Time frame: Up to 2 years
Duration of remission (DoR)
Time frame: Up to 2 years
CR rate
Time frame: Up to 2 years
Composite remission rate
Time frame: Up to 2 years
Proportion of patients receiving a haematopoietic stem cell transplant (HSCT)
Time frame: Up to 2 years
Proportion of pateints who achieve CR with MRD negativity
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liposomal cytarabine-daunorubicin for injection and 7+3 (cytarabine and daunorubicin) in people with High-risk (Secondary) Acute Myeloid Leukemia, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. 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 15 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 28 Dec 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (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 28 Dec 2023.