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Also known as Vyxeos
Vyxeos/ Liposome · 1 trial · 2 indications
To establish the recommended phase 2 dose of Vyxeos®/CPX-351 in combination with clofarabine in children with relapsed/refractory AML
| Arm | Type | Description |
|---|---|---|
| Treatment with Vyxeos®/CPX-351 in combination with clofarabine | EXPERIMENTAL | Treatment will consist of 2 courses. An adapted regimen is used to combine Vyxeos®/CPX-351 at a fixed dose given at day 1, 3, 5 with clofarabine at the allocated dose level given at day 2-6 in course one, and only Vyxeos®/CPX-351 in course 2. A maximum of 3 dose levels of clofarabine are expected to be tested in this study. |
| Name | Type | Description |
|---|---|---|
| Vyxeos 44 MG / 100 MG Liposome Injection | DRUG | Vyxeos®/CPX-351 will be infused in 90 minutes on day 1, 3 and 5 only, 3 hours after the end of clofarabine (if administered on the same day). |
| Clofarabine | DRUG | Clofarabine infusion will be given according to the assigned dose level, over 2 hours IV, daily on day 2-6 (for 5 consecutive days). |
We will include pediatric patients ≥1 year and ≤21 years with: * Any ≥ 2nd relapse of AML * Refractory AML (defined as ≥ 20% blasts in the bone marrow after standard (re-) induction therapy) * Early 1st relapse (defined as relapse within one year from initial diagnosis) of AML * Any relapse of AML ...
Vyxeos is a liposome injection being studied for use in acute myeloid leukemia (AML) and relapsed or refractory pediatric AML. It is also being evaluated in high-risk myelodysplastic syndrome in the context of allogeneic stem cell transplantation. Vyxeos is an investigational small molecule therapy in clinical development.
Vyxeos is developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker JAZZ. The company is conducting clinical trials to evaluate Vyxeos in hematologic malignancies, including acute myeloid leukemia and relapsed pediatric AML.
Vyxeos is in Phase 2 clinical development for acute myeloid leukemia and high-risk myelodysplastic syndrome. A separate Phase 1 trial is evaluating Vyxeos in combination with clofarabine for relapsed or refractory pediatric AML. Vyxeos remains investigational and is not yet approved by regulatory authorities.
Vyxeos is being studied in two clinical trials. NCT04217278 is a Phase 2 trial in adults with AML and high-risk myelodysplastic syndrome undergoing allogeneic stem cell transplantation, enrolling 333 participants in the United Kingdom. NCT07156435 is a Phase 1 trial combining Vyxeos with clofarabine in pediatric patients with relapsed or refractory AML across multiple European countries.
Yes, Vyxeos is also known as Vyxeos 44 MG / 100 MG Liposome Injection and Vyxeos/ Liposome. These names refer to the same liposomal formulation of the drug. The 44 mg and 100 mg designations indicate the two active components in the liposome injection.
Vyxeos is a liposome injection containing two chemotherapy agents, daunorubicin and cytarabine, in a synergistic 1:5 molar ratio. The liposomal formulation is designed to deliver both drugs to leukemia cells. Vyxeos is being studied in acute myeloid leukemia and related hematologic conditions.