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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
Must not have
Active signs or symptoms of central nervous system (CNS) involvement by malignancy (lumbar puncture [LP] not required). Prior 7+3 remission induction chemotherapy for MDS or AML More than 2 lines of prior non-intensive therapy. New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia on rhythm control strategy or on pacemaker, uncontrolled hypertension (blood pressure > 160 systolic and > 110 diastolic not responsive to antihypertensive medication) Acute myocardial infarction in the previous 12 weeks (from the start of treatment). Any serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent. Any active malignancy (unrelated, non-hematological malignancy) diagnosed within the past 6 months of starting the study drug (other than curatively treated carcinoma-in-situ of the cervix or non-melanoma skin cancer). History of allergic reactions attributed to compounds of similar chemical or biologic composition to CPX-351. Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Known history of HIV or active hepatitis B or C. No major surgery within 2 weeks prior to study enrollment. Pregnant or breast feeding Male and female participants who are fertile who do not agree to use an effective barrier methods of birth control (i.e. abstinence) to avoid pregnancy while receiving study treatment and for 30 days after last dose of study treatment. Non-childbearing is defined as > 1 year postmenopausal or surgically sterilized. Acute promyelocytic leukemia (APL)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response rate (ORR) per 2003 IWG criteria
Overall response rate (ORR) per 2003 International Working Group (IWG) criteria
Secondary study objectives
Duration of response (DOR)
Event-free survival (EFS)
Overall Survival (OS)
+1 more

Side effects data

From 2015 Phase 3 trial • 309 Patients • NCT01696084
68%
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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1170

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
467 Previous Clinical Trials
32,642 Total Patients Enrolled
Sudipto Mukherjee, MD, PhDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center
3 Previous Clinical Trials
175 Total Patients Enrolled

Media Library

CPX-351 (Liposomal Anthracycline; Cytidine Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04668885 — Phase 2
Myelodysplastic Syndrome Research Study Groups: Primary refractory/relapsed AML, MDS after HMA failure
Myelodysplastic Syndrome Clinical Trial 2023: CPX-351 Highlights & Side Effects. Trial Name: NCT04668885 — Phase 2
CPX-351 (Liposomal Anthracycline; Cytidine Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04668885 — Phase 2
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