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Leukemia, Myeloid, AcutePhase 2NCT06770257

Daunorubicin, Cytarabine Liposomes Plus Venetoclax vs Azacitidine Plus Venetoclax in AML Patients Unfit for Intensive Chemotherapy

A Phase 2 study testing daunorubicin, cytarabine liposomes, Azacitidine and Venetoclax in people with Leukemia, Myeloid, Acute, run by Institute of Hematology & Blood Diseases Hospital, China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Daunorubicin, Cytarabine Liposomes(CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.) is a dual-drug liposomal encapsulation of cytarabine and daunorubicin at a fixed 5:1 synergistic molar ratio. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Myeloid, Acute
What is being tested?
daunorubicin, cytarabine liposomes, Azacitidine and Venetoclax
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
10 Dec 2025to 10 Jun 2027
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must have confirmation of Acute Myeloid Leukemia (AML) by 2022 World Health Organization (WHO) criteria, previously untreated.
  • Participant must be >= 18 years of age.
  • Participant must have a projected life expectancy of at least 12 weeks.
  • Participant must be considered ineligible for intensive induction therapy defined by the following:
  • >= 75 years of age; b. >= 18 to 74 years of age with at least one of the following comorbidities: i. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3; ii. Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction <= 50% or chronic stable angina; iii. Diffusing capacity of the Lung for Carbon Monoxide (DLCO) <= 65% or Forced Expiratory Volume in 1 second (FEV1) <= 65%; iv. Creatinine clearance >= 30 mL/min to < 45 ml/min; v. Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 × Upper Limit of Normal (ULN); vi. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.
  • Participant must have an ECOG Performance status:
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  • 0 to 2 for Participants >= 75 years of age or 0 to 3 for Participants >= 18 to 74 years of age. 6.Laboratory values meet the following criteria:
  • Serum alanine aminotransferase or aspartate aminotransferase≤3 × ULN, ≤5 × ULN for patients with liver involvement.
  • For participants of ≥ 75 years old: Serum total bilirubin≤1.5 × ULN, ≤3 × ULN for patients with liver involvement
  • For participants of 18 to 74 years old: Serum total bilirubin≤ 3× ULN
  • Adequate renal function as demonstrated by a creatinine >= 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.
  • 7.Male participants who are sexually active, must agree, from Study Day 1 through at least 6 months after the last dose of study drug, to practice the protocol specified contraception and agree to refrain from sperm donation during this period.
  • 8.Female participants of childbearing potential must practice the protocol specified contraception from Study Day 1 through at least 6 months after the last dose of study drug. Female participants must agree to refrain from preganancy, breastfeeding or egg donation during this period. Female participants of childbearing potential must have negative results for pregnancy test performed: At Screening with a serum sample obtained within 7 days prior to the first study drug administration.
  • 9.Participant must able to understand the study and voluntarily sign informed consent.
  • -

Who cannot join

  • White blood cell count>25 × 10 ^ 9/L (treatment with hydroxyurea or leukocyte isolation is allowed);
  • Acute promyelocytic leukemia (APL);
  • Previously received treatment with vinaclor or demethylating drugs or other chemotherapy drugs for AML or MDS (excluding the use of hydroxyurea before study administration)
  • AML participants with good cytogenetic characteristics, including T (8; 21)/RUNX1:: RUNX1T1 or inv16/CBFB:: MYH11；
  • AML secondary to MPN (including myelofibrosis, polycythemia vera, primary thrombocytosis, CML) and accompanied by BCR: AML participants of ABL1;
  • AML participants with known central nervous system involvement;
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  • Within 6 months prior to the first administration, there is active cardiovascular disease, including but not limited to the following conditions: myocardial infarction, unstable angina, uncontrolled arrhythmia, and grade III/IV heart failure (New York Heart Association standard, NYHA); Hypertension that is still poorly controlled after antihypertensive treatment (with three consecutive measurements of systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 90mmHg during the screening period).
  • hepatitis B B surface antigen (HBsAg) positive/hepatitis B B core antibody (HBcAb) positive, HBV DNA higher than the measurable lower limit or 1000 copies/mL (500IU/mL) (whichever is lower), HCV antibody positive and HCV RNA higher than the measurable lower limit or 1000 copies/mL (whichever is lower);
  • History of immunodeficiency, including positive HIV antibody test;
  • Have used other clinical trial drugs for treatment within one month before receiving treatment;
  • Participants who received potent or moderate cytochrome P450 3A (CYP3A) inducers/inhibitors or P-glycoprotein (P-gp) inhibitors within 7 days prior to commencing study treatment;
  • Participants have consumed grapefruit, grapefruit products, Seville oranges (including jam containing Seville oranges), or starfruit within 3 days prior to the first administration of the study drug.
  • Have a history of allergic reactions to the ingredients of the research drug (and its excipients) and/or other similar products;
  • Wilson's disease history or other history of copper metabolism abnormalities;
  • Participants with cumulative exposure to anthracycline drugs exceeding 339 mg/m2 of daunorubicin (or equivalent drug dose level);
  • Pregnancy or lactation period;
  • Participants who are unable to take oral medication, have malabsorption syndrome, or suffer from other diseases that hinder enteral administration;
  • Uncontrolled active infections (viruses, bacteria, or fungi) (the infection must be controllable for at least 3 consecutive days with normal body temperature and stable hemodynamics in co infected participants using antibiotics)
  • History of other malignant tumors within the past 3 years or concurrent active malignant tumors, excluding: 1) cervical carcinoma in situ or breast carcinoma in situ that has received adequate treatment; 2) basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; 3) localized malignant tumors that have been surgically removed (or treated in other ways) for the purpose of cure;
  • Suffer from any serious and/or uncontrollable disease that may affect the participants' participation in this study as determined by the investigator (including but not limited to chronic respiratory disease requiring continuous oxygen inhalation, diabetes not effectively controlled, kidney disease requiring dialysis, serious liver disease, life-threatening autoimmune disease and hemorrhagic disease, drug abuse, nervous system disease, etc.);
  • There are other situations deemed unsuitable by the researchers to participate in the study.

About this study

Official title: A Randomized Phase ll Study Evaluating the Efficacy and Safety of Combination Therapy of Daunorubicin, Cytarabine Liposomes and Venetoclax Versus Combination Therapy of Azacitidine and Venetoclax in Newly Diagnosed AML Patients Not Eligible for Intensive Chemotherapy

Daunorubicin, Cytarabine Liposomes(CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.) is a dual-drug liposomal encapsulation of cytarabine and daunorubicin at a fixed 5:1 synergistic molar ratio.

This is a phase 2, randomized, controlled study in patients who are >= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for intensive induction therapy.

Read more

In this study, patients will be randomized by 1:1:1 to receive Daunorubicin, Cytarabine Liposomes + Venetoclax(14d) or Daunorubicin, Cytarabine Liposomes + Venetoclax(21d) or Venetoclax + Azacitidine.

Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit.

Being tested
daunorubicin, cytarabine liposomes, Azacitidine, Venetoclax
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.

  • daunorubicin, cytarabine liposomesDrug

    First induction: 100 units/m^2 by 90-minute IV infusion on Days 1, 3, 5. Second induction: 100 units/m^2 by 90-minute IV infusion on Days 1 and 3. Consolidation therapy: 65 units/m^2 by 90-minute IV infusion on Days 1 and 3.

  • AzacitidineDrug

    Given SC on days 1-7

  • VenetoclaxDrug

    Given PO on days 1-14 or 1-21 or 1-28

Study groups in NCT06770257
Study groupRoleWhat they receive
ArmA（daunorubicin, cytarabine liposomes plus 14d-venetolcax）ExperimentalPatients receive daunorubicin, cytarabine liposomes through intravenous injection(IV) on days 1、3、5, and venetoclax orally（PO） daily on days 1-14. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: daunorubicin, cytarabine liposomes; Drug: Venetoclax
ArmB（daunorubicin, cytarabine liposomes plus 28d-venetolcax）ExperimentalPatients receive daunorubicin, cytarabine liposomes IV on days 1、3、5, and venetoclax PO daily on days 1-28. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: daunorubicin, cytarabine liposomes; Drug: Venetoclax
ArmC（azacitidine plus 28d-venetoclax）Active comparatorPatients receive azacitidine subcutaneously (SC) on days 1-7, and venetoclax PO daily on days 1-28. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Azacitidine; Drug: Venetoclax

What is being measured

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

  1. Complete remission rate(CR)

    Proportion of patients with complete remission during the treatment period.

    Measured: Up to 8 months

Secondary outcomes (4)

  1. Composite complete remission rate(cCR)

    Proportion of CR and complete remission with incomplete count recovery(CRi)

    Measured: Up to 8 months

  2. Proportion of pateints who achieve Measurable residual disease（MRD） negativity

    The percentage of patients who are MRD negative

    Measured: Up to 8 months

  3. Event-free survival (EFS)

    EFS is defined as the time from study randomization to the date of induction treatment failure, disease relapse or death from any cause, whichever occurs first.

    Measured: Up to 2 years

  4. Overall survival (OS)

    Overall survival will be measured from the date of randomization to death from any cause.

    Measured: Up to 2 years

Timeline

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

  1. First posted13 Jan 2025
  2. Study start10 Dec 2025 (estimated)
  3. Primary completion10 Dec 2026 (estimated)
  4. Study completion10 Jun 2027 (estimated)

Why it stopped: The project was terminated as the genetic office did not approve it.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06770257
Sponsor's protocol ID
IIT2024082
Status last verified
Dec 2024
First submitted
7 Jan 2025
Last updated
3 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing daunorubicin, cytarabine liposomes, Azacitidine and Venetoclax in people with Leukemia, Myeloid, Acute, run by Institute of Hematology & Blood Diseases Hospital, 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 15 inclusion and 21 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: withdrawn, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete remission rate(CR) (time frame: Up to 8 months). 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 NCT06770257.

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 3 Jun 2025.

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