Floatz Rating
B61/100
Confidence
Indicative
Sponsor
National Cancer Institute (NCI)
Modality
UNKNOWN
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
63High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT05554419CT.gov 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 | — | — | — |
NCT07008638CT.gov Phase I/II Clinical Trial of Proteasome Inhibitor in Combination With CPX-351 for the Treatment of Newly-Diagnosed TP53-mutated Acute Myeloid Leukemia (AML) | — | Recruiting | — | — | — |
NCT05628623CT.gov Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia (AML) Following Initial Treatment | — | Not Yet Recruiting | — | — | — |
NCT05554406CT.gov Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) | — | Recruiting | — | — | — |
NCT05564390CT.gov MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) | — | Recruiting | — | — | — |
NCT05829434CT.gov Magrolimab Plus Intensive Chemotherapy in Newly Diagnosed AML or HR-MDS | — | Withdrawn | — | — | — |
NCT05627232CT.gov Tazemetostat and Palbociclib With CPX-351for R/R AML | — | Recruiting | — | — | — |
NCT05320380CT.gov A Study of the Drug IMGN632 in Children With Leukemia That Has Come Back After Treatment or is Difficult to Treat | — | Withdrawn | — | — | — |
NCT04990102CT.gov Phase IB/II of CPX-351 for Relapse Prevention in AML | — | Recruiting | — | — | — |
NCT04802161CT.gov Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes | — | Active Not Recruiting | — | — | — |
Show 37 more trialsShow fewer
NCT04982354CT.gov Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia | — | Withdrawn | — | — | — |
NCT04992949CT.gov Evaluation of CPX-351 Monotherapy in Acute Myeloid Leukemia Secondary to Myeloproliferative Neoplasm | — | Completed | — | — | — |
NCT05169307CT.gov CPX-351 Real-World Effectiveness and Safety Study | — | Completed | — | — | — |
NCT04526288CT.gov CPX-351 Versus Immediate Stem Cell Transplantation for the Treatment of High-Grade Myeloid Cancers With Measurable Residual Disease | — | Terminated | — | — | — |
NCT04269213CT.gov CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old | — | Active Not Recruiting | — | — | — |
NCT04915612CT.gov Liposomal Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin for the Treatment of Relapsed Refractory Pediatric Patients With Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT04049539CT.gov Vyxeos for Re-induction Treatment of Acute Myeloid Leukemia Patients With Persistent Disease After Induction | — | Recruiting | — | — | — |
NCT04668885CT.gov CPX-351 as a Novel Approach for the Treatment of Older Patients With AML and MDS | — | Active Not Recruiting | — | — | — |
NCT04493164CT.gov CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome | — | Recruiting | — | — | — |
NCT04293562CT.gov A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations | — | Recruiting | — | — | — |
NCT04209725CT.gov A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT04195945CT.gov CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients | — | Active Not Recruiting | — | — | — |
NCT04128748CT.gov Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome | — | Active Not Recruiting | — | — | — |
NCT04230239CT.gov Clinical Trial to Assess the Efficacy and Toxicity of Induction and Consolidation With CPX-351 for Patients Aged 60 to 75 Years With Secondary or High-risk Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT04075747CT.gov A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT04038437CT.gov A Trial of CPX-351 Lower Intensity Therapy (LIT) Plus Venetoclax as First Line Treatment for Subjects With AML | — | Completed | — | — | — |
NCT03897127CT.gov Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics | — | Active Not Recruiting | — | — | — |
NCT03988205CT.gov Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT03878927CT.gov CPX-351+GO in Subjects 55 Years Old, or Older, With AML | — | Terminated | — | — | — |
NCT04061239CT.gov Comparison of Therapies Before Stem Cell Transplantation in Patients With Higher Risk MDS and Oligoblastic AML | — | Recruiting | — | — | — |
NCT03904251CT.gov CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT03844997CT.gov Phase I/II Trial of CPX-351 + Palbociclib in Patients With Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT03825796CT.gov CPX-351 Plus Enasidenib for Relapsed AML | — | Active Not Recruiting | — | — | — |
NCT03555955CT.gov A Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351 | — | Completed | — | — | — |
NCT03672539CT.gov Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome | — | Active Not Recruiting | — | — | — |
NCT03629171CT.gov Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia | — | Recruiting | — | — | — |
NCT03335267CT.gov Investigator Initiated Trial of CPX-351 for Untreated Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT02286726CT.gov CPX-351 in Treating Patients With Newly Diagnosed, High-Risk Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT02269579CT.gov Pharmacokinetic and Pharmacodynamic Assessment of Treatment With CPX-351 (Cytarabine: Daunorubicin) Liposome for Injection in Acute Leukemias and MDS Patients With Moderate Hepatic Impairment | — | Withdrawn | — | — | — |
NCT02272478CT.gov Trial to Test the Effects of Adding 1 of 2 New Treatment Agents to Commonly Used Chemotherapy Combinations | — | Unknown | — | — | — |
NCT02238925CT.gov An Open Label Phase II Pharmacokinetic and Pharmacodynamic Assessment of the Potential for QTc Prolongation Following First Induction Treatment With CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Acute Leukemias and MDS Patients | — | Completed | — | — | — |
NCT01943682CT.gov Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma | — | Completed | — | — | — |
NCT01696084CT.gov Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT03393611CT.gov CPX-351 Salvage Therapy Followed by Haplo-Cord Transplant for Relapsed/Refractory Leukemia or Myelodysplastic Syndrome | — | Completed | — | — | — |
NCT00875693CT.gov A Novel Sequential Treatment of Salvage and Reduced Intensity Conditioning (RIC) Chemotherapy for Allogeneic Stem-Cell Transplantation (SCT) for Primary Refractory and Relapsed Acute Myelogenous Leukemia (AML) | — | Completed | — | — | — |
NCT00822094CT.gov Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML) | — | Completed | — | — | — |
NCT00788892CT.gov Trial of CPX-351 in Newly Diagnosed Elderly AML Patients | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Acute Myeloid Leukemia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Cpx-351 (this asset) | National Cancer Institute (NCI) | Approved | B · 61 |
| Gemtuzumab | M.D. Anderson Cancer Center | P4 | A |
| Amsacrine | University Hospital, Toulouse | P4 | BBB |
| Posaconazole | AstraZeneca | P4 | BBB |
| (+)-Vincristine | Janssen Research & Development, LLC | P3 | BBB |
| Aclacinomycin | Chinese PLA General Hospital | P4 | BB |
| Alvocidib | M.D. Anderson Cancer Center | P2 | BB |
| Prednisone | Children's Oncology Group | P3 | BB |
| Therapeutic Allogeneic Lymphocytes | University of Southern California | P2 | BB |
+42 more in the Acute Myeloid Leukemia cohort
Other indications for Cpx-351
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Therapy Related Acute Myeloid Leukemia And Myelodysplastic Syndrome | — | P2 | BB · 67 |
| Myelodysplastic Syndrome | — | P2/3 | B · 63 |
| Myeloproliferative Neoplasm | — | P2 | B · 60 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Cpx-351 in Acute Myeloid Leukemia. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/cpx-351-acute-myeloid-leukemia
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