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Anti-tumor antibiotic
CPX-351 for Acute Myeloid Leukemia
Phase 1 & 2
Recruiting
Led By Catherine Lai, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects who are of non-reproductive potential or use highly effective methods of birth control
Adequate renal function with estimated Creatinine Clearance greater than or equal to 30 ml/min (Cockcroft-Gault based on actual weight)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year after end of treatment
Awards & highlights
Study Summary
This trial is testing a new cancer drug, CPX-351, to see what the best dose is. Patients will keep taking the drug for 6 cycles as long as it is working, and the dose will be lowered if there are side effects.
Who is the study for?
Adults over 18 with newly diagnosed Acute Myeloid Leukemia (AML) who are in complete remission, have undergone certain treatments up to a year, and can't have an allogeneic bone marrow transplant. Participants must be able to start treatment within 3 months of their last remission, have good heart function and organ health, and agree to use effective birth control.Check my eligibility
What is being tested?
The trial is testing CPX-351 for preventing AML relapse. It involves a dose de-escalation design where patients receive maintenance doses on specific days across six cycles. The safest maximum dose determined will be used in the phase II part of the study.See study design
What are the potential side effects?
CPX-351 may cause side effects such as fatigue, fever, nausea or vomiting, mouth sores, diarrhea or constipation; low blood counts leading to increased risk of infection or bleeding; shortness of breath; rash; liver problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am either not able to have children or I use effective birth control methods.
Select...
My kidneys work well enough, with a creatinine clearance rate of 30 ml/min or more.
Select...
I can take care of myself but may not be able to do heavy physical work.
Select...
I've had up to 6 cycles or a year of treatment with specific drugs for my condition.
Select...
I am over 18 and have recently been diagnosed.
Select...
I have been diagnosed with a specific type of leukemia (not M3).
Select...
I am a man and agree to use effective birth control methods.
Select...
My cancer is in complete remission.
Select...
My liver tests are within normal limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year after end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year after end of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Inicidence of Treatment Emergent Adverse events (Phase 2)
Maximum tolerate dose (Phase 1)
Secondary outcome measures
Event free survival (Phase 1 and 2)
Incidence of Treatment Emergent Adverse Events (Phase 1)
Overall Survival (Phase 1 and 2)
+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%
Haemoptysis
8%
Dysgeusia
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%
Streptococcus Test Positive
1%
Bronchopulmonary Aspergillosis
1%
Streptococcal Sepsis
1%
Pseudomonas Test Positive
1%
Haemorrhage Intracranial
1%
Urinary Tract Infection
1%
Mental Status Changes
1%
Stenotrophomonas Test Positive
1%
Hepatic Enzyme Increased
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 Treatment1 Intervention
Dose Level 1: CPX-351 administered through intravenou infusion on Day 1 and Day 3 of 28 day cycle for 6 cycles or Dose Level -1: CPX-351 administered through intravenous infusion on Day 1 of each 28 day cycle for 6 cycles.
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?
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,478 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,835 Previous Clinical Trials
47,310,646 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,335 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the general efficacy of CPX-351 in oncology patients?
"There are 276 active studies investigating CPX-351, 67 of which are in Phase 3. While the majority of these trials are based in New york City, there are 12,438 locations worldwide where CPX-351 is being studied."
Answered by AI
Can new patients sign up to participate in this research project?
"This clinical trial, which was first posted on October 1st 2022, is actively seeking participants according to clinicaltrials.gov."
Answered by AI
What illnesses or conditions does CPX-351 show promise in helping?
"CPX-351 is a common treatment for acute myelocytic leukemia. This medication can also be administered to patients with blast phase chronic myelocytic leukemia, lymphoma, and to prophylactically prevent meningeal leukemia."
Answered by AI
What are the objectives of this clinical trial?
"The primary outcome of this clinical trial is the incidence of treatment-emergent adverse events over a 28-day period. Secondary outcomes include overall survival and relapse-free survival, both of which will be measured in phases 1 and 2 of the trial. Additionally, the study will also look at the incidence of treatment-emergent adverse events in phase 1 to determine the safety and tolerability of CPX-351 in newly diagnosed AML patients."
Answered by AI
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