Comparing two treatments for elderly patients with acute myeloid leukemia

A Randomized, Open-label, Two-period, Two-way Crossover Bioequivalence Study of Two (Cytarabine: Daunorubicin) Liposome for Injection in Elderly AML Subjects

This study is testing if a new liposome treatment for acute myeloid leukemia works as well as an existing treatment in older patients who are in remission.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 55 Years to 75 Years
• Sex: All
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Tianjin)
• Trial ID: NCT05801835 on ClinicalTrials.gov

What this trial studies

This study aims to determine the bioequivalence of (cytarabine: daunorubicin) liposome for injection compared to Vyxeos in elderly patients with acute myeloid leukemia (AML). It is a multi-center, randomized, open-label study involving a two-period, two-sequence, two-way crossover design. Patients aged 55-75 who have achieved complete remission or complete remission with incomplete blood count recovery after induction treatment will be enrolled. Blood samples will be collected for pharmacokinetic analysis to assess the drug concentrations in the plasma.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 55-75 with acute myeloid leukemia who have achieved complete remission or complete remission with incomplete blood count recovery.

Not a fit: Patients diagnosed with acute promyelocytic leukemia will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for elderly patients with acute myeloid leukemia.

How similar studies have performed: Other studies have shown success with similar bioequivalence approaches in cancer treatments, suggesting potential for this study's success.

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.

Where this trial is running

Tianjin

• Institute of Hematology and Hospital of Blood Disease, Chinese Academy of Medical Sciences — Tianjin, China (RECRUITING)

Study contacts

• Principal investigator: Jianxiang Wang, MD — Chinese Academy of Medical Sciences & Peking Union Medical College
• Study coordinator: Jianxiang Wang, MD

Conditions: Acute Myeloid Leukemia