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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Tianjin, China
        • Recruiting
        • Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Junyuan Qi, Chief doctor

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient volunteers to participate in this study and sign the informed consent form.
  2. Aged 55-70 years, no gender limitation.
  3. Patient has a diagnosis of untreated AML according to WHO criteria.
  4. Eastern Cooperation Oncology Group (ECOG) performance status of 0~1.
  5. Patient has a life expectancy of 3 months or longer.
  6. Patients can be followed up as required by the study.

  7. Patient must meet the following criteria as indicated on the clinical laboratory tests within 7 days prior to treatment :

    1. White Blood Cell Count≤ 50 x 10^9;
    2. Serum creatinine ≤ 1.5 x ULN
    3. Serum total bilirubin ≤ 1.5 x ULN; ≤3 x ULN in patients with liver infiltration
    4. Serum aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN;≤ 5 x ULN in patients with liver infiltration
    5. Coagulation function INR or PT ≤ 1.5 x ULN; APTT ≤ 1.5 x ULN
  8. Left ventricular ejection fraction ≥ 50% as assessed by echocardiography or cardiac scan with multiple uptakes gated acquisition (MUGA).
  9. Patients with mean value of triplicate Fridericia-corrected QT interval (QTcF) in the screening period, male < 450 ms, female < 470 ms.
  10. 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:

  1. Patient has a diagnosis of acute promyelocytic leukemia (APL).
  2. AML with central nervous system (CNS) involvement.
  3. 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).
  4. Patient with prior exposures to daunorubicin or other anthracyclines, or cytarabine.
  5. 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.
  6. Patients who have undergone major surgery or received radiotherapy within 4 weeks before the first study dose.
  7. 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.
  8. 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.
  9. Patient has a history of stroke or intracranial hemorrhage within 6 months before the first study dose.
  10. Patient has severe lung disease within 2 weeks before the first study dose.
  11. Patient has an active uncontrolled infection (acute or chronic fungal, bacterial, viral or other infections).
  12. Incapacity to give informed consent owe to any severe medical reasons, laboratory abnormalities or mental illness .
  13. Patients who have severe allergic reactions or be intolerable to liposome preparation ingredients.
  14. Patients with hepatolenticular degeneration or other abnormal copper metabolism.
  15. 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.
  16. Patients who have a special diet such as grapefruit within 48 hours before the first study dose.
  17. Patients have received other clinical trial drugs within 28 days before screening.
  18. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • Vyxeos

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics（PK） of Daunorubicin Cytarabine liposomes.
Time Frame: up to12 days
Maximum concentration (Cmax) .
up to12 days
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).
predose and up to 24 hours post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
up to 1 years
Overall Response Rate (ORR)
Time Frame: up to 1 years
The number and percentage of CR and CRi in each group were calculated
up to 1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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