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Anti-tumor antibiotic
CPX-351 for Acute Myeloid Leukemia
Phase 4
Waitlist Available
Led By Laura Michaelis, MD
Research Sponsored by Medical College of Wisconsin
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 day 60
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests an outpatient care model for patients receiving CPX-351. It includes nurse education and quality of life surveys to support patients without needing hospital stays.
Eligible Conditions
- Acute Myeloid Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 60
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Adherent to Readmission Recommendations
Number of Participants Adherent to Recommendations
Side effects data
From 2015 Phase 3 trial • 309 Patients • NCT0169608468%
Febrile Neutropenia
49%
Nausea
46%
Diarrhoea
42%
Constipation
41%
Oedema Peripheral
35%
Headache
35%
Epistaxis
35%
Fatigue
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%
Pneumonia
18%
Mucosal Inflammation
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%
Abdominal Distension
12%
Haemorrhoids
10%
Mouth Haemorrhage
9%
Rash Maculo-Papular
9%
Erythema
9%
Stomatitis
9%
Dyspepsia
9%
Asthenia
9%
Night Sweats
9%
Blood Blister
8%
Dysgeusia
8%
Fluid Overload
8%
Bacteraemia
8%
Transfusion Reaction
8%
Haemoptysis
8%
Sepsis
8%
Gingival Bleeding
8%
Oedema
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%
Urinary Incontinence
6%
Ecchymosis
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%
Pollakiuria
5%
Deep Vein Thrombosis
5%
Myalgia
5%
Dry Skin
5%
Hiccups
5%
Tachypnoea
5%
Dysuria
5%
Atrial Fibrillation
5%
Conjunctival Haemorrhage
5%
Chest Discomfort
5%
Agitation
4%
Acute Respiratory Failure
4%
Disease Progression
4%
Delirium
4%
Rash Erythematous
3%
Syncope
3%
Muscular Weakness
3%
Gastrooesophageal Reflux Disease
3%
Skin Lesion
3%
Oral Pain
3%
Hallucination
3%
Alopecia
3%
Weight Decreased
2%
Central Nervous System Haemorrhage
2%
Myocardial Infarction
2%
Somnolence
1%
Streptococcus Test Positive
1%
Cerebral Haemorrhage
1%
Mental Status Changes
1%
Haemorrhage Intracranial
1%
Fungal Test Positive
1%
Stenotrophomonas Test Positive
1%
Pancytopenia
1%
Euthyroid Sick Syndrome
1%
Hypothyroidism
1%
Urinary Tract Infection
1%
Enterococcus Test Positive
1%
Hepatic Enzyme Increased
1%
Neutropenia
1%
Pneumonia Bacterial
1%
Bacteroides Bacteraemia
1%
Streptococcal Sepsis
1%
Pseudomonas Test Positive
1%
Staphylococcus Test Positive
1%
Staphylococcal Bacteraemia
1%
Bronchopulmonary Aspergillosis
1%
Sinusitis Fungal
1%
Skin Infection
1%
Pneumonia Aspiration
1%
Pneumothorax
1%
Transfusion-Related Acute Lung Injury
1%
Alloimmunisation
1%
Anaemia
1%
Thrombocytopenia
1%
Cardiac Failure
1%
Cardiac Arrest
1%
Cardiac Failure Congestive
1%
Cardiomyopathy
1%
Mitral Valve Incompetence
1%
Pericarditis
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%
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)
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment2 Interventions
The study intervention is the application of a prescribed outpatient care model including a nurse teacher educational program and quality of life surveys for both subjects and caregivers. Induction therapy and medical follow up are performed without prophylactic admission to an inpatient facility. Subjects will also receive CPX-351 according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPX-351
2022
Completed Phase 3
~1170
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
627 Previous Clinical Trials
1,179,853 Total Patients Enrolled
Laura Michaelis, MDPrincipal Investigator - Medical College of Wisconsin
Froedtert & The Medical College of Wisconsin
Harvard Medical School (Residency)
1 Previous Clinical Trials
650 Total Patients Enrolled
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