AzTrials
AzTrials

Acute Myeloid LeukemiaNCT05801835

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

A study testing (cytarabine: daunorubicin) liposome for injection and Vyxeos in people with Acute Myeloid Leukemia, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 to 75 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
(cytarabine: daunorubicin) liposome for injection and Vyxeos
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
25 Aug 2023to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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
  • Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study.
  • Any subject whom the Investigator believes will not be a good candidate for the study.

Trial locations and contacts

1 site in 1 country.

Jianxiang Wang, MD contact

86-022-23909120

wangjx@ihcams.an.cn

China1 site, 1 recruiting

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

    Tianjin

    Jianxiang Wang, MD, 86-022-23909120, wangjx@ihcams.an.cn

    Jianxiang Wang, MD

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
(cytarabine: daunorubicin) liposome for injection, Vyxeos
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • (cytarabine: daunorubicin) liposome for injectionDrug

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

  • VyxeosDrug

    Also called CPX-351

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

  • (cytarabine: daunorubicin) liposome for injectionDrug

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

  • VyxeosDrug

    Also called CPX-351

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

Study groups in NCT05801835
Study groupRoleWhat they receive
Sequence A (T-R)Experimental(cytarabine: daunorubicin) liposome for injection followed by Vyxeos
Receives: Drug: (cytarabine: daunorubicin) liposome for injection; Drug: Vyxeos
Sequence B (R-T)ExperimentalVyxeos followed by (cytarabine: daunorubicin) liposome for injection
Receives: Drug: Vyxeos; Drug: (cytarabine: daunorubicin) liposome for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Maximum (peak) plasma drug concentration is a Pharmacokinetic parameter

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

  2. 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

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

Secondary outcomes (9)

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

    Maximum (peak) plasma drug concentration is a Pharmacokinetic parameter

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

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

    Area under the plasma concentration-time curve from time zero to time 48 hours is a Pharmacokinetic parameterencapsulated and toal cytarabine and daunorubicin after Day 3 treatment of each period.

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

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

    Maximum (peak) plasma drug concentration is a Pharmacokinetic parameter

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

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

    Area under the plasma concentration-time curve from time zero to time 48 hours is a Pharmacokinetic parameterencapsulated and toal cytarabine and daunorubicin after Day 3 treatment of each period.

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

  5. Incidence of treatment-emergent adverse events (TEAEs)

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

  6. Complete remission rate

    Proportion of subjects with complete remission

    Measured: Up to 1 year.

  7. Composite remission rate

    Proportion of subjects with complete response (CR) or complete response with incomplete count recovery (CRi)

    Measured: Up to 1 year.

  8. Relapse-free survival

    From the date of remission to the date of relapse after CR/CRi, or death, whichever occurs first.

    Measured: Up to 3 years.

  9. Proportion of subjects who achieve complete remission with MRD negativity

    Measured: Up to 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2023
  2. Study start25 Aug 2023
  3. Primary completionApr 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05801835
Sponsor's protocol ID
HC1702-003
Status last verified
Sep 2023
First submitted
13 Mar 2023
Last updated
21 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing (cytarabine: daunorubicin) liposome for injection and Vyxeos in people with Acute Myeloid Leukemia, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jianxiang Wang, MD (86-022-23909120, wangjx@ihcams.an.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum (peak) plasma drug concentration (Cmax) of daunorubicin cytarabine liposomes (time frame: 30 minutes before administration and 1.5, 2, 5,9,24,48,72,120,168hours after administration of Day 1.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05801835.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in