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Anti-tumor antibiotic

CPX-351 for Acute Myeloid Leukemia (V-FAST Trial)

Phase 1
Waitlist Available
Research Sponsored by Jazz Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights

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.

Eligible Conditions
  • Acute Myeloid Leukemia

V-FAST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the Recommended Phase 2 Dose (RP2D)
Safety and Tolerability of CPX-351 and Targeted Agents: incidence of adverse events (AEs) and dose limiting toxicities (DLTs)
Secondary outcome measures
Proportion of subjects who have achieved CR / CRh with MRD negative status
Proportion of subjects who have achieved CR / CRi with MRD negative status
Proportion of subjects who have achieved CR, CRi, CRh, CR + CRi, CR + CRh, and morphologic leukemia-free state (MLFS)

Side effects data

From 2015 Phase 3 trial • 309 Patients • NCT01696084
68%
Febrile Neutropenia
49%
Nausea
46%
Diarrhoea
42%
Constipation
41%
Oedema Peripheral
35%
Epistaxis
35%
Fatigue
35%
Headache
33%
Cough
33%
Decreased Appetite
29%
Rash
27%
Chills
25%
Vomiting
24%
Dyspnoea
24%
Insomnia
22%
Abdominal Pain
22%
Pyrexia
21%
Dizziness
20%
Hypotension
20%
Hypoxia
19%
Hypertension
18%
Mucosal Inflammation
18%
Pneumonia
18%
Oropharyngeal Pain
17%
Pleural Effusion
16%
Arthralgia
15%
Pruritus
15%
Anxiety
14%
Tachycardia
14%
Petechiae
14%
Back Pain
13%
Confusional State
13%
Pain In Extremity
12%
Haemorrhoids
12%
Abdominal Distension
10%
Mouth Haemorrhage
9%
Erythema
9%
Rash Maculo-Papular
9%
Stomatitis
9%
Dyspepsia
9%
Asthenia
9%
Night Sweats
9%
Blood Blister
8%
Fluid Overload
8%
Haemoptysis
8%
Dysgeusia
8%
Sepsis
8%
Gingival Bleeding
8%
Oedema
8%
Bacteraemia
8%
Transfusion Reaction
8%
Procedural Pain
8%
Fall
8%
Neck Pain
8%
Pulmonary Oedema
8%
Rales
7%
Respiratory Failure
7%
Hyperhidrosis
7%
Wheezing
7%
Vision Blurred
7%
Dry Mouth
7%
Chest Pain
7%
Catheter Site Pain
7%
Musculoskeletal Pain
7%
Depression
7%
Renal Failure Acute
7%
Haematuria
7%
Rash Pruritic
6%
Ecchymosis
6%
Urinary Incontinence
6%
Abdominal Pain Upper
6%
Nasal Congestion
6%
Mouth Ulceration
6%
Ejection Fraction Decreased
6%
Dysphagia
6%
Catheter Site Erythema
6%
Cellulitis
6%
Contusion
5%
Dry Skin
5%
Pollakiuria
5%
Deep Vein Thrombosis
5%
Hiccups
5%
Tachypnoea
5%
Dysuria
5%
Atrial Fibrillation
5%
Conjunctival Haemorrhage
5%
Chest Discomfort
5%
Myalgia
5%
Agitation
4%
Acute Respiratory Failure
4%
Disease Progression
4%
Delirium
4%
Rash Erythematous
3%
Gastrooesophageal Reflux Disease
3%
Syncope
3%
Skin Lesion
3%
Oral Pain
3%
Muscular Weakness
3%
Hallucination
3%
Alopecia
3%
Weight Decreased
2%
Central Nervous System Haemorrhage
2%
Myocardial Infarction
2%
Somnolence
1%
Cerebral Haemorrhage
1%
Bacteroides Bacteraemia
1%
Staphylococcal Bacteraemia
1%
Pneumonia Bacterial
1%
Streptococcus Test Positive
1%
Bronchopulmonary Aspergillosis
1%
Streptococcal Sepsis
1%
Pseudomonas Test Positive
1%
Haemorrhage Intracranial
1%
Urinary Tract Infection
1%
Mental Status Changes
1%
Stenotrophomonas Test Positive
1%
Hepatic Enzyme Increased
1%
Skin Infection
1%
Pneumonia Aspiration
1%
Pneumothorax
1%
Transfusion-Related Acute Lung Injury
1%
Alloimmunisation
1%
Anaemia
1%
Thrombocytopenia
1%
Neutropenia
1%
Pancytopenia
1%
Cardiac Failure
1%
Cardiac Arrest
1%
Cardiac Failure Congestive
1%
Cardiomyopathy
1%
Mitral Valve Incompetence
1%
Pericarditis
1%
Euthyroid Sick Syndrome
1%
Hypothyroidism
1%
Small Intestinal Disorders
1%
Chron's Disease
1%
Gastric Haemorrhage
1%
Lower Gastrointestinal Haemorrhage
1%
Multi-Organ Failure
1%
Death
1%
Non-Cardiac Chest Pain
1%
Cholecystitis Acute
1%
Bile Duct Stone
1%
Septic Shock
1%
Enterococcal Bacteraemia
1%
Diverticulitis
1%
Enterobacter Bacteraemia
1%
Mycotic Aneurysm
1%
Neutropenic Infection
1%
Pseudomonal Bacteraemia
1%
Sinusitis
1%
Sinusitis Fungal
1%
Staphylococcus Test Positive
1%
Enterococcus Test Positive
1%
Fungal Test Positive
1%
Dehydration
1%
Lactic Acidosis
1%
Acute Myeloid Leukaemia
1%
Acute Myeloid Leukaemia Recurrent
1%
Myelodysplastic Syndrome
1%
Renal Cell Carcinoma
1%
Carotid Artery Stenosis
1%
Cerebral Infarction
1%
Convulsion
1%
Presyncope
1%
Radiculopathy
1%
Acute Respiratory Distress Syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (CPX-351)
Arm B (7+3)

V-FAST Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm CExperimental Treatment2 Interventions
Group II: Arm BExperimental Treatment2 Interventions
Group III: Arm AExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPX-351
2022
Completed Phase 3
~1090
Venetoclax
2019
Completed Phase 3
~1990
Enasidenib
2020
Completed Phase 2
~560
Midostaurin
2018
Completed Phase 3
~1640

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,302 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI
~11 spots leftby Apr 2025