Acute Myeloid LeukemiaNCT04920500
Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients
A study testing Daunorubicin Cytarabine liposome for injection and Vyxeos、Daunorubicin Cytarabine liposome for injection in people with Acute Myeloid Leukemia, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.
Trial summary
A Randomized, Double-blind, Multiple-Dose, Two-Cycle, Parallel-Group, Bioequivalence pretrial of Daunorubicin Cytarabine liposome for Injection in older, naive patients with Acute Myeloid Leukemia (AML). Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Daunorubicin Cytarabine liposome for injection and Vyxeos、Daunorubicin Cytarabine liposome for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2020to 30 Jun 2021
- 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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient volunteers to participate in this study and sign the informed consent form.
- Aged 55-70 years, no gender limitation.
- Patient has a diagnosis of untreated AML according to WHO criteria.
- Eastern Cooperation Oncology Group (ECOG) performance status of 0~1.
- Patient has a life expectancy of 3 months or longer.
- Patients can be followed up as required by the study.
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- Patient must meet the following criteria as indicated on the clinical laboratory tests within 7 days prior to treatment :
- White Blood Cell Count≤ 50 x 10^9;
- Serum creatinine ≤ 1.5 x ULN
- Serum total bilirubin ≤ 1.5 x ULN; ≤3 x ULN in patients with liver infiltration
- Serum aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN;≤ 5 x ULN in patients with liver infiltration
- Coagulation function INR or PT ≤ 1.5 x ULN; APTT ≤ 1.5 x ULN
- Left ventricular ejection fraction ≥ 50% as assessed by echocardiography or cardiac scan with multiple uptakes gated acquisition (MUGA).
- Patients with mean value of triplicate Fridericia-corrected QT interval (QTcF) in the screening period, male < 450 ms, female < 470 ms.
- Female or male patients of childbearing age agree to take effective contraception (such as intrauterine device [IUD], contraceptives or condoms) from the date of signing an informed consent to 180 days after the last dose and female patients must be non-lactating with a negative pregnancy test within 7 days.
Who cannot join
- Patient has a diagnosis of acute promyelocytic leukemia (APL).
- AML with central nervous system (CNS) involvement.
- Patient has been previously diagnosed with another malignancy (except in the following cases: Patients with cured basal or squamous cell skin cancer, superficial bladder cancer, breast or cervical carcinoma in situ or focal prostate cancer with a Gleason score of 6).
- Patient with prior exposures to daunorubicin or other anthracyclines, or cytarabine.
- The interval between any treatment medication (conventional or investigational) for MDS and the first administration of this study is less than 2 weeks. However, the interval between the first medication of this study and hydroxyurea which used to inhibit the rapid proliferation of the tumor could be ≥ 24 hours. The study treatment should be held until the toxicity be reduced to Grade 1 or below.
- Patients who have undergone major surgery or received radiotherapy within 4 weeks before the first study dose.
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- Patients who suffered from active cardiovascular diseases including but not limited to: poorly controlled hypertension (ie. systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 90 mmHg ), myocardial infarction, unstable angina, uncontrolled arrhythmia, heart failure NYHA class III/IV within 6 months before the first study dose.
- Patient has a history of severe bleeding, such as hemophilia A, hemophilia B, von Willebrand disease or spontaneous bleeding that requires blood transfusion or other medical intervention.
- Patient has a history of stroke or intracranial hemorrhage within 6 months before the first study dose.
- Patient has severe lung disease within 2 weeks before the first study dose.
- Patient has an active uncontrolled infection (acute or chronic fungal, bacterial, viral or other infections).
- Incapacity to give informed consent owe to any severe medical reasons, laboratory abnormalities or mental illness .
- Patients who have severe allergic reactions or be intolerable to liposome preparation ingredients.
- Patients with hepatolenticular degeneration or other abnormal copper metabolism.
- Patients with positive hepatitis B surface antigen or hepatitis B core antibody with hepatitis B virus DNA > ULN by quantitative assay, positive hepatitis C antibody or positive HIV antibody.
- Patients who have a special diet such as grapefruit within 48 hours before the first study dose.
- Patients have received other clinical trial drugs within 28 days before screening.
- Patients are not suitable for the study in the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences
Tianjin
Junyuan Qi, Chief doctor, 022-23909067, qijy@ihcams.ac.cn
Junyuan Qi, Chief doctor
About this study
Official title: A Randomized, Double-blind, Multiple-Dose, Two-Cycle, Parallel-Group, Bioequivalence Pretrial of Daunorubicin Cytarabine Liposome for Injection in Older, Naive AML Patients
A Randomized, Double-blind, Multiple-Dose, Two-Cycle, Parallel-Group, Bioequivalence pretrial of Daunorubicin Cytarabine liposome for Injection in older, naive patients with Acute Myeloid Leukemia (AML).
Read the detailed description
Bioequivalence Study of Daunorubicin Cytarabine liposome for injection, 100 units (CHINO Pharmaceutical Group Shijiazhuang Pharmaceutical Co Ltd), versus Vyxeos®, 100 units (Jazz Pharmaceuticals Public Limited Company), in patients with AML .
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Daunorubicin Cytarabine liposome for injection, Vyxeos、Daunorubicin Cytarabine liposome for injection
- 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.
Daunorubicin Cytarabine liposome for injectionDrug
Induction 1: [100 U/m²] i.v. d1,3,5 Induction 2: [100 U/m²] i.v. d1,3
Vyxeos、Daunorubicin Cytarabine liposome for injectionDrug
Also called Vyxeos
Induction 1: [100 U/m²] i.v. Vyxeos（d1）,Daunorubicin Cytarabine liposome for injection（d3、d5） Induction 2: [100 U/m²] i.v. Daunorubicin Cytarabine liposome for injection（d1、d3 ）
| Study group | Role | What they receive |
|---|---|---|
| Daunorubicin Cytarabine liposome for injection | Experimental | Induction 1: Daunorubicin Cytarabine liposome for injection [100 U/m²] i.v. (120 min±10min) d1,3,5 Induction 2: Daunorubicin Cytarabine liposome for injection [100 U/m²] i.v. (120 min±10min) d1,3 Consolidation therapy: Daunorubicin Cytarabine liposome for injection [65 U/m²] i.v. (>90 min) d1,3 Receives: Drug: Daunorubicin Cytarabine liposome for injection |
| Vyxeos + Daunorubicin Cytarabine liposome for injection | Active comparator | Induction 1: Vyxeos[100 U/m²] i.v. (120 min) d1; Daunorubicin Cytarabine liposome for injection [100 U/m²] i.v. (120 min±10min) d3,5 Induction 2: Daunorubicin Cytarabine liposome for injection [100 U/m²] i.v. (120 min±10min) d1,3 Consolidation therapy: Daunorubicin Cytarabine liposome for injection [65 U/m²] i.v. (>90 min) d1,3 Receives: Drug: Vyxeos、Daunorubicin Cytarabine liposome for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics（PK） of Daunorubicin Cytarabine liposomes.
Maximum concentration (Cmax) .
Measured: up to12 days
PK of Daunorubicin Cytarabine liposomes.
Area under the concentration curve at each cycle D1 (AUC0-24).
Measured: predose and up to 24 hours post-dose
Secondary outcomes (2)
Safety assessed by adverse events
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal investigational) product, whether or not related to the medicinal (investigational) product.
Measured: up to 1 years
Overall Response Rate (ORR)
The number and percentage of CR and CRi in each group were calculated
Measured: up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start4 Sep 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920500
- Sponsor's protocol ID
- HC1702-BE-001
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2021
- Last updated
- 9 Jun 2021
- 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 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multiple-Dose, Two-Cycle, Parallel-Group, Bioequivalence Pretrial of Daunorubicin Cytarabine Liposome for Injection in Older, Naive AML Patients
- ClinicalTrials.gov ID
- NCT04920500
- Acronym / sponsor ID
- HC1702-BE-001
- Conditions
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 9 Jun 2021 (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.
A Randomized, Double-blind, Multiple-Dose, Two-Cycle, Parallel-Group, Bioequivalence pretrial of Daunorubicin Cytarabine liposome for Injection in older, naive patients with Acute Myeloid Leukemia (AML).
Detailed description
Bioequivalence Study of Daunorubicin Cytarabine liposome for injection, 100 units (CHINO Pharmaceutical Group Shijiazhuang Pharmaceutical Co Ltd), versus Vyxeos®, 100 units (Jazz Pharmaceuticals Public Limited Company), in patients with AML .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daunorubicin Cytarabine liposome for injection | Experimental | Drug: Daunorubicin Cytarabine liposome for injectionInduction 1: Daunorubicin Cytarabine liposome for injection [100 U/m²] i.v. (120 min±10min) d1,3,5 Induction 2: Daunorubicin Cytarabine liposome for injection [100 U/m²] i.v. (120 min±10min) d1,3 Consolidation therapy: Daunorubicin Cytarabine liposome for injection [65 U/m²] i.v. (>90 min) d1,3 |
| Vyxeos + Daunorubicin Cytarabine liposome for injection | Active comparator | Drug: Vyxeos、Daunorubicin Cytarabine liposome for injectionInduction 1: Vyxeos[100 U/m²] i.v. (120 min) d1; Daunorubicin Cytarabine liposome for injection [100 U/m²] i.v. (120 min±10min) d3,5 Induction 2: Daunorubicin Cytarabine liposome for injection [100 U/m²] i.v. (120 min±10min) d1,3 Consolidation therapy: Daunorubicin Cytarabine liposome for injection [65 U/m²] i.v. (>90 min) d1,3 |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patient volunteers to participate in this study and sign the informed consent form.
- Aged 55-70 years, no gender limitation.
- Patient has a diagnosis of untreated AML according to WHO criteria.
- Eastern Cooperation Oncology Group (ECOG) performance status of 0~1.
- Patient has a life expectancy of 3 months or longer.
Key exclusion criteria (18 listed)
- Patient has a diagnosis of acute promyelocytic leukemia (APL).
- AML with central nervous system (CNS) involvement.
- Patient has been previously diagnosed with another malignancy (except in the following cases: Patients with cured basal or squamous cell skin cancer, superficial bladder cancer, breast or cervical carcinoma in situ or focal prostate cancer with a Gleason score of 6).
- Patient with prior exposures to daunorubicin or other anthracyclines, or cytarabine.
- The interval between any treatment medication (conventional or investigational) for MDS and the first administration of this study is less than 2 weeks. However, the interval between the first medication of this study and hydroxyurea which used to inhibit the rapid proliferation of the tumor could be ≥ 24 hours. The study treatment should be held until the toxicity be reduced to Grade 1 or below.
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 |
|---|---|---|
| Daunorubicin Cytarabine liposome for injectionInduction 1: [100 U/m²] i.v. d1,3,5 Induction 2: [100 U/m²] i.v. d1,3 | Drug | Daunorubicin Cytarabine liposome for injection |
| Vyxeos、Daunorubicin Cytarabine liposome for injectionAlso: VyxeosInduction 1: [100 U/m²] i.v. Vyxeos（d1）,Daunorubicin Cytarabine liposome for injection（d3、d5） Induction 2: [100 U/m²] i.v. Daunorubicin Cytarabine liposome for injection（d1、d3 ） | Drug | Vyxeos + Daunorubicin Cytarabine liposome for injection |
Primary outcome
Pharmacokinetics（PK） of Daunorubicin Cytarabine liposomes.
Time frame: up to12 days
Maximum concentration (Cmax) .
PK of Daunorubicin Cytarabine liposomes.
Time frame: predose and up to 24 hours post-dose
Area under the concentration curve at each cycle D1 (AUC0-24).
2 secondary outcomes
Safety assessed by adverse events
Time frame: up to 1 years
Overall Response Rate (ORR)
Time frame: up to 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
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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 study testing Daunorubicin Cytarabine liposome for injection and Vyxeos、Daunorubicin Cytarabine liposome for injection in people with 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 18 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 9 Jun 2021. 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.
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 Junyuan Qi, Chief doctor (022-23909067, qijy@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics（PK） of Daunorubicin Cytarabine liposomes. (time frame: up to12 days). The study lists 2 primary outcomes in all. 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 9 Jun 2021.