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Liposomal Anthracycline; Liposomal Cytarabine
CPX-351 for Myelodysplastic Syndrome
Phase 2
Recruiting
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 day 28 +/- 7 days of induction
Awards & highlights
Study Summary
This trial is testing a new way to give an existing leukemia drug, in the hopes of helping patients whose disease has not responded to other treatments.
Eligible Conditions
- Myelodysplastic Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 28 +/- 7 days of induction
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28 +/- 7 days of induction
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of CPX-351 as measured by overall response rate (ORR)
Secondary outcome measures
Duration of response (DOR) in participants achieving a response
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%
Abdominal Distension
12%
Haemorrhoids
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%
Hyperhidrosis
7%
Respiratory Failure
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%
Abdominal Pain Upper
6%
Ecchymosis
6%
Urinary Incontinence
6%
Nasal Congestion
6%
Mouth Ulceration
6%
Ejection Fraction Decreased
6%
Dysphagia
6%
Catheter Site Erythema
6%
Cellulitis
6%
Contusion
5%
Dry Skin
5%
Deep Vein Thrombosis
5%
Pollakiuria
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%
Staphylococcal Bacteraemia
1%
Streptococcal Sepsis
1%
Cerebral Haemorrhage
1%
Bacteroides Bacteraemia
1%
Urinary Tract Infection
1%
Streptococcus Test Positive
1%
Bronchopulmonary Aspergillosis
1%
Pseudomonas Test Positive
1%
Haemorrhage Intracranial
1%
Hepatic Enzyme Increased
1%
Mental Status Changes
1%
Pneumonia Bacterial
1%
Stenotrophomonas Test Positive
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: intravenous CPX-351 with potential maintenance therapyExperimental Treatment1 Intervention
Single agent CPX-351 administered at the standard FDA approved dose of 44 mg/m2 intravenously on days 1, 3, 5 of the induction cycle. If participants achieve complete remission (CR), complete remission with incomplete count recovery (CRi) or partial remission (PR), they will be eligible to continue on to maintenance therapy, which will consist of CPX351 at a dose of 15.4 mg/m2 every 28 days. Participants can receive up to 4 cycles of maintenance therapy.
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
456 Previous Clinical Trials
32,088 Total Patients Enrolled
Sudipto Mukherjee, MD, PhDPrincipal Investigator - Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
3 Previous Clinical Trials
184 Total Patients Enrolled
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