Trials / Completed
CompletedNCT03575325
Vyxeos(CPX-351) in Adults w R/R Acute Lymphoblastic Leukemia
A Single-Arm, Open-Label Phase 2 Pilot Study of Vyxeos (CPX-351) in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study involves Vyxeos (CPX-351), a formulation of a fixed combination of the two anti-tumor drugs, cytarabine and daunorubicin that will be given as an infusion over 90 minutes. This study will use what is called a "liposome" injection. This is a special fat capsule (called a liposome) that surrounds the cytarabine and daunorubicin and protects the drugs from being eliminated/destroyed by the body.
Conditions
- Lymphoid Leukemia
- Acute Lymphoblastic Leukemia
- Refractory Acute Lymphoblastic Leukemia
- Relapsed Acute Lymphoblastic Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CPX-351 | The infusion of CPX-351 (cytarabine:daunorubicin) Liposome Injection will be performed through a central venous catheter, using an infusion pump to ensure that the drug is infused over the specified time period. |
Timeline
- Start date
- 2018-10-11
- Primary completion
- 2021-06-07
- Completion
- 2023-09-14
- First posted
- 2018-07-02
- Last updated
- 2024-12-12
- Results posted
- 2022-07-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03575325. Inclusion in this directory is not an endorsement.