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Liposome-encapsulated Daunorubicin-Cytarabine

Phase 2

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome | Small molecule | Oncology |Jazz Pharmaceuticals plc|Last Updated: Dec 23, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

Liposome-encapsulated Daunorubicin-Cytarabine · 1 trial · 4 indications

Phase 2 1
NCT04269213CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years OldAcute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
ACTIVE NOT_RECRUITING21 Analytics
PHASE2ACTIVE NOT_RECRUITING
CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old
Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Complete response rate (morphological complete remission [CR] and incomplete blood count recovery [CRi])
At day 45

Defined by the International Working Group Criteria. Will be summarized using frequencies and relative frequencies.

Secondary Endpoints

CR + CRi duration
Time from CR or CRi until relapse or last follow-up, assessed up to 5 years
Event free survival
Time from treating until disease progression/relapse, death due to disease, or last follow-up, assessed up to 5 years
Overall survival
Time from treatment until death due to any cause or last follow-up, assessed up to 5 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment (CPX-351)EXPERIMENTALINDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.

Interventions

NameTypeDescription
Liposome-encapsulated Daunorubicin-CytarabineDRUGGiven IV
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Eligibility Criteria

Age Range18 Years to 59 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Newly diagnosed: * Therapy-related acute myeloid leukemia (AML) * AML with antecedent myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) * AML with MDS-related changes (as per World Health Organization \[WHO\]) * Have an Eastern Cooperative Oncolog...

Countries:United States
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Frequently asked questions about Liposome-encapsulated Daunorubicin-Cytarabine

What is Liposome-encapsulated Daunorubicin-Cytarabine used for?

Liposome-encapsulated Daunorubicin-Cytarabine is being studied for the treatment of acute myeloid leukemia arising from previous myelodysplastic syndrome, as well as acute myeloid leukemia with myelodysplasia-related changes, secondary acute myeloid leukemia, and therapy-related acute myeloid leukemia. It is an investigational small molecule oncology therapy currently in Phase 2 clinical development.

Who makes Liposome-encapsulated Daunorubicin-Cytarabine?

Liposome-encapsulated Daunorubicin-Cytarabine is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the stock exchange under the ticker JAZZ. The company is conducting clinical trials to evaluate this investigational therapy for certain types of acute myeloid leukemia.

What phase is Liposome-encapsulated Daunorubicin-Cytarabine in?

Liposome-encapsulated Daunorubicin-Cytarabine is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants, with a planned enrollment of 21 patients.

What clinical trials is Liposome-encapsulated Daunorubicin-Cytarabine in?

Liposome-encapsulated Daunorubicin-Cytarabine is being evaluated in clinical trial NCT04269213, titled 'CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old.' This Phase 2 study is active but not recruiting, enrolls adults aged 18 years and older, and is being conducted in the United States.

Is Liposome-encapsulated Daunorubicin-Cytarabine the same as CPX-351?

Yes, Liposome-encapsulated Daunorubicin-Cytarabine is also known as CPX-351. The clinical trial NCT04269213 uses the name CPX-351 in its title, confirming that these names refer to the same investigational drug being developed by Jazz Pharmaceuticals for certain acute myeloid leukemia indications.