CPX-351
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | VYXEOS | — | 2017-08-03 | fda.gov ↗ |
Trials 58 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05320380 Background | Aug → Sep 2023 | B-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic leukemia, mixed phenotype acute leukemia | Children's Oncology Group | Withdrawn | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04802161 Background | Aug 2022 → Nov 2024 overdue | acute myeloid leukemia with multilineage dysplasia, chronic myelomonocytic leukemia, myelodysplastic syndrome, therapy related acute myeloid leukemia and myelodysplastic syndrome | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02272478 Comparator | Oct 2014 → Feb 2021 | acute myeloid leukemia, myelodysplastic syndrome | Cardiff University | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03988205 Background | Aug 2019 → Dec 2021 | acute myeloid leukemia | Medical College of Wisconsin | Terminated | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CPX-351 | “This phase II trial studies the effect of CPX-351 followed by donor stem cell transplantation versus immediate donor stem cell transplantation in treating patients with...” NCT04526288 ↗48“We aimed to evaluate the safety and preliminary activity of lower doses of CPX-351, a liposomal encapsulation of cytarabine and daunorubicin, in a single-centre, phase 1/2...” PMID 37946611 ↗ Nov 2023 “This phase II trial studies the best dose and how well liposomal cytarabine-daunorubicin CPX-351 (CPX-351) works in treating patients with newly diagnosed acute myeloid leukemia” NCT02286726 ↗ “A Phase 1/2 Study of CPX-351 (NSC# 775341) Alone Followed by Fludarabine, Cytarabine, and G-CSF (FLAG) for Children With Relapsed Acute Myeloid Leukemia (AML).” NCT02642965 ↗ “This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine (CPX-351) works in treating patients with secondary acute myeloid leukemia” NCT04269213 ↗ “This phase Ib trial studies the best dose of gemtuzumab ozogamicin when given together with CPX-351 in treating patients with acute myeloid leukemia” NCT03904251 ↗ “Patients receive CPX-351 intravenously (IV) over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity.” NCT04195945 ↗ “Induction 1:CPX-351 44 mg/m2 daunorubicin / 100 mg/m2 cytarabine i.v. (90 min) d1,3,5” NCT05260528 ↗ “The liposomal formulation of Vyxeos®/CPX-351 may be a suitable replacement for DNX” NCT07156435 ↗ “Patients receive CPX-351 intravenously (IV) over 90 minutes on days 1, 3, and 5” NCT04493164 ↗ “A Phase 2 Trial of CPX-351 Combined With Venetoclax in Relapsed or Refractory” PMID 40401707 ↗ May 2025 “Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib” NCT04128748 ↗ “liposome-encapsulated daunorubicin-cytarabine (CPX-351)” NCT03825796 ↗ “Vyxeos (CPX-351, cytarabine and daunorubicin liposome)” NCT03826992 ↗ “CPX-351 is made up of daunorubicin and cytarabine” NCT04293562 ↗ “liposomal cytarabine and daunorubicin (CPX-351)” NCT03672539 ↗ “liposomal cytarabine and daunorubicin (CPX-351)” NCT04915612 ↗ “CPX-351” NCT02019069 ↗ |
| Known as | liposomal cytarabine-daunorubicin | “This phase 2 clinical trial studies how well CPX-351 (liposomal cytarabine-daunorubicin) works in treating patients with relapsed or refractory acute myeloid leukemia or...” NCT02019069 ↗ |
| Known as | Liposomal Cytarabine-Daunorubicin CPX-351 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01804101 ↗ |
| Known as | liposome-encapsulated daunorubicin-cytarabine | “PRIMARY OBJECTIVES: I. To determine the phase II dose of the combination liposome-encapsulated daunorubicin-cytarabine (CPX-351) plus gemtuzumab ozogamicin (GO) by means of...” NCT03904251 ↗ |
| Known as | NSC# 775341 | “A Phase 1/2 Study of CPX-351 (NSC# 775341) Alone Followed by Fludarabine, Cytarabine, and G-CSF (FLAG) for Children With Relapsed Acute Myeloid Leukemia (AML).” NCT02642965 ↗ |
| Known as | VYXEOS | “CPX-351 (Europe: Vyxeos® liposomal; United States: Vyxeos®) is a dual-drug liposomal encapsulation of daunorubicin and cytarabine in a synergistic 1:5 molar ratio.” PMID 36289532 ↗ Oct 202210“Vyxeos is a combination of both chemotherapy drugs cytarabine and daunorubicin contained in a liposome.” NCT04049539 ↗ “CPX-351 (Vyxeos™) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome” NCT03572764 ↗ “The liposomal formulation of Vyxeos®/CPX-351 may be a suitable replacement for DNX” NCT07156435 ↗ “EAP of CPX-351 (VYXEOS) for Patients 60-75 Years of Age With Secondary AML” NCT02533115 ↗ |
| Known as | Vyxeos liposomal | “CPX-351 (Europe: Vyxeos® liposomal; United States: Vyxeos®) is a dual-drug liposomal encapsulation of daunorubicin and cytarabine in a synergistic 1:5 molar ratio.” PMID 36289532 ↗ Oct 2022 |
| Modality | Other / unclassified | “CPX-351 is a liposomal formulation of cytarabine:daunorubicin designed to deliver synergistic drug ratios to leukemia cells.” PMID 24687088 ↗ Mar 2014 |
| Route | Intravenous | “by 90-minute IV infusion” NCT00822094 ↗ |