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

Last updated: September 17, 2023
Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acute Myeloid Leukemia

Leukemia

Platelet Disorders

Treatment

(cytarabine: daunorubicin) liposome for injection

Vyxeos

Clinical Study ID

NCT05801835
HC1702-003
  • Ages 55-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theWorld Health Organization classification of myeloid neoplasms and acute leukemia" whohaven't been treated or who have achieved complete remission (CR) or completeremission with incomplete blood count recovery (CRi) after preceding inductiontherapy.
  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<470ms at screening.
  7. Women of childbearing potential should agree to use contraceptive measures (such asIUD, contraceptive or condom) during the study and within 6 months after the end ofthe study.

Exclusion

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 cellcarcinoma, superficial bladder cancer, cervical cancer in situ, carcinoma in situ ofbreast or prostate cancer with Gleason score <6).
  4. For subjects with induction remission who go directly to randomisation, theirantitumour drug elution is required prior to the first dose in the consolidation phasefor 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 priorto 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, cerebralhemorrhage 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 drugwithin 28 days of study start
  16. Female subjects who are pregnant, breast-feeding, or who are likely to become pregnantduring the study.
  17. Any subject whom the Investigator believes will not be a good candidate for the study.

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: (cytarabine: daunorubicin) liposome for injection
Phase:
Study Start date:
August 25, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

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

    Tianjin,
    China

    Active - Recruiting

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