Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Daunorubicin Cytarabine liposome for injection 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 |
Drug: Daunorubicin Cytarabine liposome for injection
Induction 1: [100 U/m²] i.v. d1,3,5 Induction 2: [100 U/m²] i.v. d1,3
|
| Active Comparator: Vyxeos + Daunorubicin Cytarabine liposome for injection 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 |
Drug: Vyxeos、Daunorubicin Cytarabine liposome for injection
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 ）
Other Names:
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Outcome Measures
Primary Outcome Measures
- Pharmacokinetics（PK） of Daunorubicin Cytarabine liposomes. [up to12 days]
Maximum concentration (Cmax) .
- PK of Daunorubicin Cytarabine liposomes. [predose and up to 24 hours post-dose]
Area under the concentration curve at each cycle D1 (AUC0-24).
Secondary Outcome Measures
- Safety assessed by adverse events [up to 1 years]
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.
- Overall Response Rate (ORR) [up to 1 years]
The number and percentage of CR and CRi in each group were calculated
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient volunteers to participate in this study and sign the informed consent form.
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Aged 55-70 years, no gender limitation.
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Patient has a diagnosis of untreated AML according to WHO criteria.
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Eastern Cooperation Oncology Group (ECOG) performance status of 0~1.
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Patient has a life expectancy of 3 months or longer.
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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 :
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White Blood Cell Count≤ 50 x 10^9;
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Serum creatinine ≤ 1.5 x ULN
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Serum total bilirubin ≤ 1.5 x ULN; ≤3 x ULN in patients with liver infiltration
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Serum aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN;≤ 5 x ULN in patients with liver infiltration
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Coagulation function INR or PT ≤ 1.5 x ULN; APTT ≤ 1.5 x ULN
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Left ventricular ejection fraction ≥ 50% as assessed by echocardiography or cardiac scan with multiple uptakes gated acquisition (MUGA).
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Patients with mean value of triplicate Fridericia-corrected QT interval (QTcF) in the screening period, male < 450 ms, female < 470 ms.
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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.
Exclusion Criteria:
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Patient has a diagnosis of acute promyelocytic leukemia (APL).
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AML with central nervous system (CNS) involvement.
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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).
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Patient with prior exposures to daunorubicin or other anthracyclines, or cytarabine.
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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.
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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.
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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.
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Patient has a history of stroke or intracranial hemorrhage within 6 months before the first study dose.
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Patient has severe lung disease within 2 weeks before the first study dose.
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Patient has an active uncontrolled infection (acute or chronic fungal, bacterial, viral or other infections).
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Incapacity to give informed consent owe to any severe medical reasons, laboratory abnormalities or mental illness .
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Patients who have severe allergic reactions or be intolerable to liposome preparation ingredients.
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Patients with hepatolenticular degeneration or other abnormal copper metabolism.
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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.
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Patients who have a special diet such as grapefruit within 48 hours before the first study dose.
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Patients have received other clinical trial drugs within 28 days before screening.
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Patients are not suitable for the study in the investigator's opinion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences | Tianjin | China |
Sponsors and Collaborators
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HC1702-BE-001