- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04920500
Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients
June 7, 2021 updated by: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
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).
Study Overview
Status
Unknown
Conditions
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 Type
Interventional
Enrollment (Anticipated)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Junyuan Qi, Chief doctor
- Phone Number: 022-23909067
- Email: qijy@ihcams.ac.cn
Study Locations
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-
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Tianjin, China
- Recruiting
- Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences
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Contact:
- Junyuan Qi, Chief doctor
- Phone Number: 022-23909067
- Email: qijy@ihcams.ac.cn
-
Principal Investigator:
- Junyuan Qi, Chief doctor
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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
|
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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics(PK) of Daunorubicin Cytarabine liposomes.
Time Frame: up to12 days
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Maximum concentration (Cmax) .
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up to12 days
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PK of Daunorubicin Cytarabine liposomes.
Time Frame: predose and up to 24 hours post-dose
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Area under the concentration curve at each cycle D1 (AUC0-24).
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predose and up to 24 hours post-dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety assessed by adverse events
Time Frame: 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.
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up to 1 years
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Overall Response Rate (ORR)
Time Frame: up to 1 years
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The number and percentage of CR and CRi in each group were calculated
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up to 1 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 4, 2020
Primary Completion (Anticipated)
June 30, 2021
Study Completion (Anticipated)
June 30, 2021
Study Registration Dates
First Submitted
February 5, 2021
First Submitted That Met QC Criteria
June 7, 2021
First Posted (Actual)
June 9, 2021
Study Record Updates
Last Update Posted (Actual)
June 9, 2021
Last Update Submitted That Met QC Criteria
June 7, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cytarabine
- Daunorubicin
Other Study ID Numbers
- HC1702-BE-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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