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

NCT ID: NCT05801835

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-25
• Study Completion Date: 2025-12-31

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.

Detailed Description

This is a multi-center, randomized, open-label, two-period, two-sequence, two-way crossover bioequivalence study of (cytarabine: daunorubicin) liposome for injection manufactured by CSPC Zhongnuo Pharmaceutical Technology Co., Ltd compared with Vyxeos manufactured by Jazz Pharmaceuticals, Inc. in elderly AML subjects. Patients who have achieved CR/CRi after induction treatment will be randomized to sequence A (T-R): (cytarabine: daunorubicin) liposome on C1D1 and C1D3/ Vyxeos on C2D1 and C2D3 or sequence B(R-T): Vyxeos on C1D1 and C1D3/ (cytarabine: daunorubicin) liposome on C2D1 and C2D3. Randomization will be in a 1:1 ratio. Forty to sixty subjects will be enrolled to ensure 36 evaluable subjects.

Serial blood samples for determination of liposomal encapsulated cytarabine and liposomal encapsulated daunorubicin plasma concentration for PK analysis will be obtained in each cycle.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence A (T-R)

(cytarabine: daunorubicin) liposome for injection followed by Vyxeos

Group Type: EXPERIMENTAL

(cytarabine: daunorubicin) liposome for injection

Intervention Type: DRUG

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

Vyxeos

Intervention Type: DRUG

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

Sequence B (R-T)

Vyxeos followed by (cytarabine: daunorubicin) liposome for injection

Group Type: EXPERIMENTAL

Vyxeos

Intervention Type: DRUG

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

(cytarabine: daunorubicin) liposome for injection

Intervention Type: DRUG

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

Interventions

(cytarabine: daunorubicin) liposome for injection

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

Intervention Type: DRUG

Vyxeos

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

Intervention Type: DRUG

(cytarabine: daunorubicin) liposome for injection

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

Intervention Type: DRUG

Vyxeos

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

Intervention Type: DRUG

Other Intervention Names

CPX-351; CPX-351

Eligibility Criteria

Inclusion Criteria

1. Able to understand the study and voluntarily sign informed consent.

2. Male or female between 55-75 years of age (inclusive).

3. 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.

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

5. Adequate hematopoietic, renal and liver function.

6. Cardiac function (LVEF) ≥ 50% and QTcF (Fridericia's) for male<450 ms, for female<470 ms at screening.

7. 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.

Exclusion Criteria

1. Subjects who are diagnosed as acute promyelocytic leukemia.

2. Subjects with clinical evidence of active CNS leukemia.

3. 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).

4. 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.

5. Subjects with a history of any major surgery or radiation therapy within 4 weeks prior to the first dose.

6. Subjects with active cardiovascular disease within 6 months prior to the first dose.

7. Subjects with severe hemorrhagic disorders or diseases may cause spontaneous bleeding.

8. Subjects with active or history of cerebrovascular disease, such as stroke, cerebral hemorrhage within 6 months prior to the first dose.

9. Subjects with severe pulmonary disease within 2 weeks prior to the first dose.

10. Subjects with active or uncontrolled infection.

11. Subjects with previous cumulative exposure to anthracyclines >302 mg/m^2 daunorubicin (or equivalent drug equivalent dose level).

12. Subjects with hypersensitivity to liposomal products.

13. Subjects with a history of Wilson's disease or other copper-metabolism disorder.

14. Subjects with known HIV, hepatitis B or hepatitis C infection.

15. Participation in another clinical trial or treatment with any investigational drug within 28 days of study start

16. Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study.

17. Any subject whom the Investigator believes will not be a good candidate for the study.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianxiang Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences & Peking Union Medical College

Locations

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

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianxiang Wang, MD

Role: CONTACT

wangjx@ihcams.an.cn

86-022-23909120

Facility Contacts

Jianxiang Wang, MD

Role: primary

wangjx@ihcams.an.cn

86-022-23909120

Other Identifiers

HC1702-003

Identifier Type: -

Identifier Source: org_study_id