A Bioequivalence Study of (Cytarabine: Daunorubicin) Liposome for Injection

NCT05801835 | Unknown

• 1 other identifier: HC1702-003
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the bioequivalence of (cytarabine: daunorubicin) liposome for injection and Vyxeos in elderly acute myeloid leukemia (AML) subjects.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• Maximum (peak) plasma drug concentration (Cmax) of daunorubicin cytarabine liposomes

  Maximum (peak) plasma drug concentration is a Pharmacokinetic parameter

  30 minutes before administration and 1.5, 2, 5,9,24,48,72,120,168hours after administration of Day 1.

• Area under the plasma concentration versus time curve calculated from 0 to 48h post administration (AUC0-48h) of daunorubicin cytarabine liposomes

  Area under the plasma concentration-time curve from time zero to time 48 hours is a Pharmacokinetic parameter

  30 minutes before administration and 1.5, 2, 5,9,24,48,72,120,168hours after administration of Day 1

Secondary Outcomes (9)

• Maximum (peak) plasma drug concentration (Cmax) of free daunorubicin and cytarabine

  30 minutes before administration and 1.5, 2, 5,9,24,48,72,120,168hours after administration of Day 1.

• Area under the plasma concentration versus time curve calculated from 0 to 48h post administration (AUC0-48h) of free daunorubicin and cytarabine

  30 minutes before administration and 1.5, 2, 5,9,24,48,72,120,168hours after administration of Day 1.

• Maximum (peak) plasma drug concentration (Cmax) of total daunorubicin and cytarabine

  30 minutes before administration and 1.5, 2, 5,9,24,48,72,120,168hours after administration of Day 1.

• Area under the plasma concentration versus time curve calculated from 0 to 48h post administration (AUC0-48h) of total daunorubicin and cytarabine

  30 minutes before administration and 1.5, 2, 5,9,24,48,72,120,168hours after administration of Day 1.

• Incidence of treatment-emergent adverse events (TEAEs)

  Up to 35 calendar days after the last administration of the investigational product.

Study Arms (2)

Sequence A (T-R)

EXPERIMENTAL

(cytarabine: daunorubicin) liposome for injection followed by Vyxeos

Drug: (cytarabine: daunorubicin) liposome for injection; Drug: Vyxeos

Sequence B (R-T)

EXPERIMENTAL

Vyxeos followed by (cytarabine: daunorubicin) liposome for injection

Drug: Vyxeos; Drug: (cytarabine: daunorubicin) liposome for injection

Interventions

(cytarabine: daunorubicin) liposome for injection DRUG

Be given intravenously at 65U/m\^2 on days 1 and day3 of the first cycle of induction.

Sequence A (T-R)

Vyxeos DRUG

Be given intravenously at 65U/m\^2 on days 1 and day3 of the first cycle of induction.

Also known as: CPX-351

Sequence B (R-T)

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand the study and voluntarily sign informed consent.
• Male or female between 55-75 years of age (inclusive).
• Subjects diagnosed with acute myeloid leukemia according to "The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia" who haven't been treated or who have achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after preceding induction therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Adequate hematopoietic, renal and liver function.
• Cardiac function (LVEF) ≥ 50% and QTcF (Fridericia's) for male\<450 ms, for female\<470 ms at screening.
• Women of childbearing potential should agree to use contraceptive measures (such as IUD, contraceptive or condom) during the study and within 6 months after the end of the study.

You may not qualify if:

• Subjects who are diagnosed as acute promyelocytic leukemia.
• Subjects with clinical evidence of active CNS leukemia.
• Subjects with any other active malignancy expect for those have been cured (basal cell carcinoma, superficial bladder cancer, cervical cancer in situ, carcinoma in situ of breast or prostate cancer with Gleason score \<6).
• For subjects with induction remission who go directly to randomisation, their antitumour drug elution is required prior to the first dose in the consolidation phase for a minimum of 5 half-lives or 4 weeks, whichever is shorter.
• Subjects with a history of any major surgery or radiation therapy within 4 weeks prior to the first dose.
• Subjects with active cardiovascular disease within 6 months prior to the first dose.
• Subjects with severe hemorrhagic disorders or diseases may cause spontaneous bleeding.
• Subjects with active or history of cerebrovascular disease, such as stroke, cerebral hemorrhage within 6 months prior to the first dose.
• Subjects with severe pulmonary disease within 2 weeks prior to the first dose.
• Subjects with active or uncontrolled infection.
• Subjects with previous cumulative exposure to anthracyclines \>302 mg/m\^2 daunorubicin (or equivalent drug equivalent dose level).
• Subjects with hypersensitivity to liposomal products.
• Subjects with a history of Wilson's disease or other copper-metabolism disorder.
• Subjects with known HIV, hepatitis B or hepatitis C infection.
• Participation in another clinical trial or treatment with any investigational drug within 28 days of study start

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

Liposomes; Injections; CPX-351

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Membranes, Artificial; Biomedical and Dental Materials; Drug Carriers; Dosage Forms; Pharmaceutical Preparations; Manufactured Materials; Technology, Industry, and Agriculture; Biomimetic Materials; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jianxiang Wang, MD

  Chinese Academy of Medical Sciences & Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianxiang Wang, MD

CONTACT

86-022-23909120; wangjx@ihcams.an.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 6, 2023
• Study Start: August 25, 2023
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CN (1)