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Chemotherapy

CPX-351 for Myelodysplastic Syndrome

Phase 1
Waitlist Available
Led By Meagan Jacoby, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of myelodysplastic syndrome (MDS) with an IPSS-R score of Intermediate, High or Very High (see Appendix A) AND ≥ 5% myeloblasts in the bone marrow
Left ventricular cardiac ejection fraction ≥ 50% by echocardiography or MUGA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 5 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug for safety and effectiveness in patients with myelodysplastic syndrome.

Who is the study for?
This trial is for adults aged 18-70 with higher risk Myelodysplastic Syndrome (MDS) who are eligible for a transplant. They must have good kidney, liver, and heart function, an ECOG performance status ≤2, and no history of Wilson's disease or certain viral infections. Women must not be pregnant and participants should agree to use contraception.Check my eligibility
What is being tested?
The study tests two doses of CPX-351 (Vyxeos™) in MDS patients to see which is safer and more tolerable. It also looks at how many achieve complete remission and can proceed to a bone marrow transplant after treatment.See study design
What are the potential side effects?
While the specific side effects aren't listed here, CPX-351 may include typical chemotherapy-related side effects such as fatigue, nausea, increased infection risk due to low blood cell counts, bleeding or bruising easily from low platelets.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My MDS is rated Intermediate to Very High with more than 5% myeloblasts in my bone marrow.
Select...
My heart pumps well, with an ejection fraction of 50% or higher.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am between 18 and 70 years old.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of a CPX-351 regimen in a transplant eligible, higher risk MDS population as measured by the proportion of participants who experience an adverse event by patient, type of event, and grade of event
Secondary outcome measures
Best overall response in MDS patients treated with CPX-351
Complete remission + marrow complete remission rates in patients treated with CPX-351
Muscular Dystrophy
+10 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%
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%
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%
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%
Cerebral Haemorrhage
1%
Bacteroides Bacteraemia
1%
Staphylococcal Bacteraemia
1%
Pneumonia Bacterial
1%
Hepatic Enzyme Increased
1%
Streptococcus Test Positive
1%
Bronchopulmonary Aspergillosis
1%
Urinary Tract Infection
1%
Mental Status Changes
1%
Streptococcal Sepsis
1%
Pseudomonas Test Positive
1%
Haemorrhage Intracranial
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: CPX-351Experimental Treatment4 Interventions
CPX-351 will be given according to the assigned dose level over a minimum of a 90-minutes via IV infusion on Days 1, 3, and 5 of the first induction If the treating physician elects to perform a day 14 bone marrow biopsy then, a second induction may be considered for patients in the absence of a chemoablated, hypocellular marrow on the Day 14 bone marrow assessment, if the patient has failed to achieve a marrow CR, and it is deemed safe to administer by the treating physician. The second induction uses a modified schedule in which CPX-351 will be given according to the assigned dose level on Days 1 and 3 In the absence of disease progression or unacceptable toxicity, the patient may continue to consolidation at the discretion of the treating physician or the patient may proceed to alloHCT after induction at the discretion of the treating physician
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPX-351
2022
Completed Phase 3
~1090
Research blood draw
2022
Completed Phase 2
~240

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,689 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,339 Total Patients Enrolled
Meagan Jacoby, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
583 Total Patients Enrolled

Media Library

CPX-351 (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03572764 — Phase 1
Myelodysplastic Syndrome Research Study Groups: CPX-351
Myelodysplastic Syndrome Clinical Trial 2023: CPX-351 Highlights & Side Effects. Trial Name: NCT03572764 — Phase 1
CPX-351 (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03572764 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential hazards can arise from the use of CPX-351?

"Our team judged the safety of CPX-351 to be a 1 because this is an early phase trial with limited data on its efficacy and protection."

Answered by AI

What is the aggregate number of enrollees in this research project?

"Signups for this trial are currently closed. Initially posted on December 14th 2018, the last edit was made on April 1st 2022. If seeking other studies to join, 1596 trials focusing myelodysplastic syndromes and 260 with CPX-351 as an intervention are presently recruiting volunteers."

Answered by AI

How is CPX-351 typically deployed therapeutically?

"Acute myelocytic leukemia is a common condition treated with CPX-351. Additionally, this medication can be useful in the management of blast phase chronic myelocytic leukemia and lymphoma as well as for prophylactic measures against meningeal leukemia."

Answered by AI

Has CPX-351 been subjected to any other research studies?

"Currently, there are 260 clinical trials involving CPX-351. 65 of these investigations have reached Phase 3 and the majority are located in New york City. Altogether, 12359 medical sites are running studies on this therapeutic approach."

Answered by AI

Is it possible for me to sign up as a participant in this clinical research?

"This clinical trial is searching for 20 individuals with myelodysplastic syndromes between the age of majority and 70 years old. To be eligible, applicants must meet numerous criteria including: having an Intermediate, High or Very High IPSS-R score (as per Appendix A), possessing a total bilirubin below twice the upper limit of normal, displaying no greater than three times the upper limit of normal AST/ALT levels in their serum creatinine test results, exhibiting a left ventricular cardiac ejection fraction above 50% via echocardiography or MUGA scan; be deemed suitable by their physician to"

Answered by AI

Are there still opportunities for individuals to volunteer for this experiment?

"At the moment, this trial is not actively seeking participants. It was initially posted on December 14th 2018 and last updated on April 1st 2022. For individuals looking for similar studies, there are currently 1596 trials searching for patients with myelodysplastic syndromes and 260 clinical trials in need of CPX-351 study candidates."

Answered by AI

Is the age eligibility for this medical trial limited to those below 80 years old?

"This clinical trial is only available to those aged 18-70, with 510 trials dedicated to younger participants and 1333 for seniors."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
CPX-351 (Vyxeos™) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome
2018. "CPX-351 (Vyxeos™) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03572764.
All > Mds > Myelodysplastic Syndrome
~3 spots leftby Apr 2025
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