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CPX-351 for Acute Myeloid Leukemia (V-FAST Trial)
V-FAST Trial Summary
This trial is testing a new cancer drug, CPX-351, in combination with various targeted agents in people with AML who are fit to receive intensive chemotherapy. The goal is to find the recommended phase 2 dose of CPX-351.
- Acute Myeloid Leukemia
V-FAST Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 3 trial • 309 Patients • NCT01696084V-FAST Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
In what locations is this investigation being conducted?
"Patients are being accepted at the University of Kansas Cancer Center, Johns Hopkins University and Vanderbilt Ingram Cancer Centre for this medical trial. Additionally, there are 8 additional sites that can be found on our website."
Could you please discuss the potential risks of utilizing CPX-351?
"CPX-351 received a ranking of 1 on our internal analysis scale due to it being only in Phase 1 trials, so there is limited evidence for both its efficacy and safety."
Can you provide a synopsis of other investigations regarding CPX-351?
"Currently, 472 medical trials are being carried out on the effectiveness of CPX-351, with 91 in their terminal phase. This treatment is primarily studied at Edmonton, Alberta but it spans across 19841 locations globally."
In what cases is CPX-351 typically employed as a therapeutic agent?
"CPX-351 is a commonly utilized medication to treat acute myelocytic leukemia. Additionally, this drug has been shown to be effective in managing blast phase chronic myelocytic leukemia, lymphoma, and prophylaxis of meningeal leukemia."
How many participants are being recruited for this research endeavor?
"At this juncture, this clinical trial is not actively seeking out subjects. It was first posted on December 2nd 2019 and most recently edited November 2nd 2022. For other options, there are 1535 trials admitting patients suffering from forms of leukemia, myelocytic-acute and 472 studies recruiting for CPX-351 experiments that have open spots available."
What aims has this experiment been designed to achieve?
"This long-term trial of up to 30 months shall measure the Recommended Phase 2 Dose (RP2D) as its primary outcome. Additionally, investigators will assess the Proportion of subjects who have achieved CR, CRi, and CRh; those in a morphologic leukemia-free state (MLFS); those with MRD negative status after two inductions following attaining either a CR or a CRi; and finally patients achieving both a response rate and an MRD negative status post two inductions when having attained a complete remission or partial haematological recovery prior."
Is this clinical research currently in the process of accruing participants?
"Unfortunately, this trial is no longer recruiting patients. The post first appeared on December 2nd 2019 and was last updated November 2nd 2022. For those looking to participate in other trials, there are presently 1535 studies searching for participants with leukemia, myelocytic acute and 472 concerning CPX-351 actively seeking out enrollees."
Is eligibility open to participate in this medical study?
"This clinical trial is enrolling 57 participants, aged 18 to 75 years old and affected by acute myelocytic leukemia. Additional criteria for eligibility include: ECOG performance status of 0-2; serum creatinine < 2mg/dL; serum total bilirubin < 2 mg/dL (with Gilbert's Syndrome being an exception); ALT or AST levels below 3x ULN; ejection fraction ≥ 50% from echocardiography or MUGA scans; subjects with second malignancies in remission that has been stable > 6 months off chemotherapy can be eligible - provided they are not on long-term"
Does this research study permit participants below the age of 20?
"The conditions for participating in this trial are that patients should be between 18 and 75 years old. There are 549 studies available for individuals below the age of consent, while those older than 65 have 1606 research options to choose from."
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