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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

Study Summary

This study is evaluating whether a drug called CPX-351 may help individuals with chronic obstructive pulmonary disease.

Eligible Conditions
  • Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Adherent to Readmission Recommendations
Number of Participants Adherent to Recommendations

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%
Rash Maculo-Papular
9%
Erythema
9%
Stomatitis
9%
Dyspepsia
9%
Asthenia
9%
Night Sweats
9%
Blood Blister
8%
Fluid Overload
8%
Dysgeusia
8%
Haemoptysis
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%
Syncope
3%
Gastrooesophageal Reflux Disease
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%
Pneumonia Bacterial
1%
Cerebral Haemorrhage
1%
Bacteroides Bacteraemia
1%
Staphylococcal Bacteraemia
1%
Stenotrophomonas Test Positive
1%
Pseudomonas Test Positive
1%
Hepatic Enzyme Increased
1%
Streptococcus Test Positive
1%
Haemorrhage Intracranial
1%
Bronchopulmonary Aspergillosis
1%
Urinary Tract Infection
1%
Mental Status Changes
1%
Streptococcal Sepsis
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)

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
~1090

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,598 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia
Laura Michaelis 2019. "Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03988205.
~1 spots leftby Apr 2025
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