Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients

NCT04920500 | Unknown

• 1 other identifier: HC1702-BE-001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics（PK） of Daunorubicin Cytarabine liposomes.

  Maximum concentration (Cmax) .

  up to12 days

• PK of Daunorubicin Cytarabine liposomes.

  Area under the concentration curve at each cycle D1 (AUC0-24).

  predose and up to 24 hours post-dose

Secondary Outcomes (2)

• Safety assessed by adverse events

  up to 1 years

• Overall Response Rate (ORR)

  up to 1 years

Study Arms (2)

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

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

Drug: Vyxeos、Daunorubicin Cytarabine liposome for injection

Interventions

Daunorubicin Cytarabine liposome for injection DRUG

Induction 1: \[100 U/m²\] i.v. d1,3,5 Induction 2: \[100 U/m²\] i.v. d1,3

Daunorubicin Cytarabine liposome for injection

Vyxeos、Daunorubicin Cytarabine liposome for injection DRUG

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 ）

Also known as: Vyxeos

Vyxeos + Daunorubicin Cytarabine liposome for injection

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.: lead

Study Sites (1)

Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Injections

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Junyuan Qi, Chief doctor

CONTACT

022-23909067; qijy@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: June 9, 2021
• Study Start: September 4, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: June 9, 2021

Record last verified: 2021-02

Locations

CN (1)