Liposome-encapsulated Daunorubicin-Cytarabine

Phase 3Small molecule

Liposome-encapsulated Daunorubicin-Cytarabine is one of 124 small molecule programs targeting Acute Myeloid Leukemia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

123

Competitors

Pipeline

Status by Indication[3][1]

Indication

Acute Myeloid LeukemiaActive, not recruiting

Blasts More Than 5 Percent of Bone Marrow Nucleated CellsRecruiting

Chronic Myelomonocytic LeukemiaRecruiting

Myelodysplastic SyndromeRecruiting

Relapsed AMLActive, not recruiting

R/R AMLRecruiting

Acute Myeloid LeukemiaPhase 3

Active, not recruiting

Blasts More Than 5 Percent of Bone Marrow Nucleated CellsPreclinical

Recruiting

Chronic Myelomonocytic LeukemiaPhase 1

Recruiting

Myelodysplastic SyndromePhase 2

Recruiting

Relapsed AMLPhase 2

Active, not recruiting

R/R AMLPhase 1

Recruiting

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Idamycin

Pfizer

Phase 3

59 2

Novantrone

Pfizer

Phase 3

34 3

Xospata

Astellas

Phase 3

24 4

Fludara

Sanofi

Phase 3

17 5

Cerubidine

EEastern Cooperative Oncology Group

Phase 3

42 6

Vanflyta

Daiichi Sankyo

Phase 3

14 7

Neupogen

EEastern Cooperative Oncology Group

Phase 3

31 8

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

30 9

Nexavar

Cellcept

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Acute Myeloid Leukemia

NCT03629171

Q1 2027

Phase 2Recruiting

Acute Myeloid Leukemia

NCT05554406

Q2 2027

Phase 2Active, not recruiting

Acute Myeloid Leukemia

NCT04802161

PreclinicalRecruiting

Blasts More Than 5 Percent of Bone Marrow Nucleated Cells

NCT04049539

Q4 2027

Phase 1/2Recruiting

Myelodysplastic Syndrome

NCT04128748

Phase 1Recruiting

Chronic Myelomonocytic Leukemia

NCT03896269

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia13 trials

Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia Following Initial Treatment, The ERASE Study (A MyeloMATCH Treatment Trial)

Not yet recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05554419·184 enrolled

Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia

Completed·UUniversity of Nebraska·Phase 2·NCT03226418·75 enrolled

Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03629171·52 enrolled

Show 10 more trials

Liposomal Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin for the Treatment of Relapsed Refractory Pediatric Patients With Acute Myeloid Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT04915612·1 enrolled

CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia

Terminated·JJonsson Comprehensive Cancer Center·Phase 1·NCT03904251·13 enrolled

CPX-351 in Treating Patients With Newly Diagnosed, High-Risk Acute Myeloid Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02286726·56 enrolled

Liposome-encapsulated Daunorubicin-Cytarabine, Fludarabine Phosphate, Cytarabine, and Filgrastim in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed·CChildren's Oncology Group·Phase 1/2·NCT02642965·38 enrolled

Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05564390·2,000 enrolled

A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7 + 3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined by MYELOMATCH; A MYELOMATCH SubStudy

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05554406·335 enrolled

A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

Recruiting·CChildren's Oncology Group·Phase 3·NCT04293562·1,400 enrolled

Phase II Investigator Sponsored Study of CPX-351 in Combination With Ivosidenib for Patients With IDH1 Mutated Acute Myeloid Leukemia or High-Risk MDS

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04493164·30 enrolled

Randomized Phase 2 Study of Daunorubicin and Cytarabine Liposome + Pomalidomide Versus Daunorubicin and Cytarabine Liposome in Newly Diagnosed AML With MDS-Related Changes

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04802161·49 enrolled

Randomized Phase 2 Trial of CPX-351 (Vyxeos) vs. CLAG-M (Cladribine, Cytarabine, G-CSF, and Mitoxantrone) in Medically Less-Fit Adults With Acute Myeloid Leukemia (AML) or Other High-Grade Myeloid Neoplasm

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT04195945·60 enrolled

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome2 trials

A Phase II Study of CPX-351 in Younger Patients < 60 Years Old With Secondary Acute Myeloid Leukemia

Completed·RRoswell Park Cancer Institute·Phase 2·NCT04269213·21 enrolled

A Pilot Study of Liposomal Cytarabine and Daunorubicin (CPX-351) in Combination With Gemtuzumab Ozogamicin (GO) in Relapsed Refractory Patients With Acute Myeloid Leukemia (AML) and Post-Hypomethylating Agent (Post-HMA) Failure High-Risk Myelodysplastic Syndrome (HR-MDS)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT03672539·50 enrolled

Myeloproliferative Neoplasms1 trial

Testing the Effect of Taking Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Phase Myeloproliferative Neoplasms

Completed·OOhio State University Comprehensive Cancer Center·Phase 1/2·NCT03878199·12 enrolled

Measurable Residual Disease1 trial

CPX-351 Versus Immediate Stem Cell Transplantation for the Treatment of High-Grade Myeloid Cancers With Measurable Residual Disease

Terminated·FFred Hutchinson Cancer Center·Phase 2·NCT04526288·1 enrolled

Relapsed AML1 trial

CPX-351 Plus Enasidenib for Relapsed AML

Active, not recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT03825796·2 enrolled

5 more indications

Leukemia1 trial

A Study of the Drug IMGN632 in Children With Leukemia That Has Come Back After Treatment or is Difficult to Treat

Withdrawn·CChildren's Oncology Group·Phase 1/2·NCT05320380

Myelodysplastic Syndrome1 trial

Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04128748·52 enrolled

Chronic Myelomonocytic Leukemia1 trial

CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT03896269·38 enrolled

R/R AML1 trial

Tazemetostat and Palbociclib With CPX-351for R/R AML

Recruiting·TThomas Jefferson University·Phase 1·NCT05627232·24 enrolled

Blasts More Than 5 Percent of Bone Marrow Nucleated Cells1 trial

Open-Label Phase 2 Trial of Vyxeos in Patients With Intermediate and High-Risk Acute Myeloid Leukemia Who Have Failed an Initial Cycle of Standard Cytarabine and Daunorubicin Chemotherapy

Recruiting·OOhio State University Comprehensive Cancer Center·Preclinical·NCT04049539·28 enrolled

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for Liposome-encapsulated Daunorubicin-Cytarabine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Liposome-encapsulated Daunorubicin-Cytarabine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Liposome-encapsulated Daunorubicin-Cytarabine. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — M.D. Anderson Cancer Center company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: MM.D. Anderson Cancer Center

Liposome-encapsulated Daunorubicin-Cytarabine

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q4 2027

Trials by Indication[1]

Acute Myeloid Leukemia13 trials

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome2 trials

Myeloproliferative Neoplasms1 trial

Measurable Residual Disease1 trial

Relapsed AML1 trial

Leukemia1 trial

Myelodysplastic Syndrome1 trial

Chronic Myelomonocytic Leukemia1 trial

R/R AML1 trial

Blasts More Than 5 Percent of Bone Marrow Nucleated Cells1 trial

References

Drug Info

Quick Facts

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