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Liposomal Anthracycline; Cytidine Analog
CPX-351 for Acute Myeloid Leukemia
Phase 2
Waitlist Available
Led By Sudipto Mukherjee, MD, PhD
Research Sponsored by Case Comprehensive Cancer Center
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 at 5 years
Awards & highlights
Study Summary
This trial is studying lower doses of CPX-351 to see how well they work in treating patients with relapsed/refractory AML or MDS who have failed treatment with HMA.
Who is the study for?
This trial is for older adults with relapsed/refractory acute myeloid leukemia (AML) who can't have intensive chemotherapy, or those with myelodysplastic syndromes (MDS) unresponsive to prior treatments. Participants should be in fairly good health otherwise, able to perform daily activities with minimal help (ECOG <=2), and have normal liver and kidney function.Check my eligibility
What is being tested?
The study tests lower doses of CPX-351 on participants to see how effective it is against AML and MDS when standard therapies fail. It's aimed at those who are older or cannot tolerate more aggressive treatment options.See study design
What are the potential side effects?
CPX-351 may cause side effects such as fatigue, fever, bleeding or bruising easily due to low blood cell counts, nausea or vomiting, shortness of breath, and increased risk of infections. The severity can vary from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR) per 2003 IWG criteria
Overall response rate (ORR) per 2003 International Working Group (IWG) criteria
Secondary outcome measures
Duration of response (DOR)
Event-free survival (EFS)
Overall Survival (OS)
+1 moreSide effects data
From 2015 Phase 3 trial • 309 Patients • NCT0169608468%
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%
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%
Cerebral Haemorrhage
1%
Bacteroides Bacteraemia
1%
Staphylococcal Bacteraemia
1%
Stenotrophomonas Test Positive
1%
Pneumonia Bacterial
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
2Treatment groups
Experimental Treatment
Group I: Primary refractory/relapsed AMLExperimental Treatment1 Intervention
Lower dose CPX-351 in participants with primary refractory/relapsed AML. Participants will receive an induction and maintenance phase of CPX-351
Group II: MDS after HMA failureExperimental Treatment1 Intervention
Lower dose CPX-351 in participants with MDS after HMA failure. Participants will receive an induction and maintenance phase of CPX-351
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?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,897 Total Patients Enrolled
Sudipto Mukherjee, MD, PhDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center
3 Previous Clinical Trials
196 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Primary refractory/relapsed AML
- Group 2: MDS after HMA failure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research still recruiting patients to participate?
"The website clinicaltrials.gov indicates that this trial is not currently looking for participants. The study was first posted on 1/14/2021 and was last updated on 11/8/2022. Although this particular trial isn't searching for patients, there are 1664 other trials that are actively seeking volunteers right now."
Answered by AI
Does CPX-351 put people at risk for serious health complications?
"CPX-351 received a 2 because, while there is evidence of its safety from Phase 2 trials, there is no data supporting efficacy."
Answered by AI
What are the goals of this experiment?
"The purpose of this trial is to assess the Overall Response Rate (ORR) according to 2003 International Working Group (IWG) criteria, over the course of 5 years. Additionally, the study will monitor for secondary objectives including Duration of Response (DOR), Overall Survival (OS), and Event-free survival (EFS). DOR will be measured from time of achieving response to progression of disease, while OS and EFS will be measured from start of treatment to death or last follow up. Data analysis will include Wilcoxon rank test for continuous variables and Kaplan-Meier method for estimation of overall survival function."
Answered by AI
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