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Chemotherapy
CPX-351 + Glasdegib for Acute Myeloid Leukemia
Phase 2
Recruiting
Led By Deepa Jeyakumar, MD
Research Sponsored by University of California, Irvine
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 from the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Awards & highlights
Study Summary
This trial is testing a new cancer drug, CPX-351, to see if it is effective in treating leukemia.
Who is the study for?
Adults over 18 with newly diagnosed, untreated Acute Myelogenous Leukemia (AML) that's related to prior therapy or myelodysplastic syndromes. Participants must have good heart function and organ health, not be pregnant or breastfeeding, agree to use birth control, and cannot have certain heart conditions, uncontrolled infections, other active cancers requiring treatment, or a history of severe medical disorders.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining two drugs: CPX-351 (a chemotherapy drug) and Glasdegib (a targeted therapy), in treating AML. It's an open-label study where all participants receive the same treatment without a comparison group.See study design
What are the potential side effects?
Possible side effects include nausea, vomiting, diarrhea; low blood cell counts leading to increased infection risk; fatigue; liver problems; muscle pain; shortness of breath; and potential for heart rhythm abnormalities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with Event-Free Survival at 6 months
Secondary outcome measures
Durability of Response
Hemopoietic stem cell transplant
Overall Response Rate
+3 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%
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%
Abdominal Pain Upper
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%
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%
Pneumonia Bacterial
1%
Urinary Tract Infection
1%
Cerebral Haemorrhage
1%
Bacteroides Bacteraemia
1%
Staphylococcal Bacteraemia
1%
Streptococcus Test Positive
1%
Bronchopulmonary Aspergillosis
1%
Streptococcal Sepsis
1%
Stenotrophomonas Test Positive
1%
Pseudomonas Test Positive
1%
Haemorrhage Intracranial
1%
Hepatic Enzyme Increased
1%
Mental Status Changes
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-351 and GlasdegibExperimental Treatment2 Interventions
In Induction, subjects receive 44mg/m2/100mg/m2 IV on days 1, 3 and 5 and Glasdegib 100mg PO daily on days 6 to 28.
If re-induction is needed: Subjects receive 44mg/m2/100mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
In consolidation: Subjects receive 29mg/m2/65mg/m2 IV on days 1 and 3 and Glasdegib 100mg PO daily on days 4 to 28.
If maintenance is required, Subjects receive Glasdegib 100mg PO daily for up to one year
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glasdegib
FDA approved
Daunorubicin
FDA approved
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,996 Total Patients Enrolled
University of California, IrvineLead Sponsor
544 Previous Clinical Trials
1,923,013 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,255 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have had a heart attack or severe heart issue in the last year.I am HIV positive.I don't have any severe illnesses that would stop me from following the study's treatment plan.I have a history of gastrointestinal absorption issues.I can take care of myself and am up and about more than half of my waking hours.I am a woman who could potentially become pregnant.My lifetime dose of anthracycline is below 386mg/m2.My leukemia affects my brain, spinal cord, or testicles.My AML has a FLT3 mutation and may need midostaurin treatment, or I have specific genetic changes but can still join the study.I have AML and haven't been treated with cytarabine or daunorubicin.I have taken a pregnancy test within the last 72 hours and it was negative.I agree to use two forms of birth control or abstain from sex during and for 120 days after the study.I have a history of Wilson's disease or a similar condition.My bilirubin levels are below 2.0 mg/dL, or high due to Gilbert's disease.My heart pumps well, with an ejection fraction over 50%.I agree to use a condom during sex with women who can have children, from the start of the study until 120 days after it ends.I do not have active hepatitis B or C, or I have successfully completed treatment for hepatitis C.I haven't had a heart attack in the last 6 months and my heart condition is stable.My AML involves major cell abnormalities without certain genetic mutations.I have previously been treated with Glasdegib or CPX-351.I do not have any uncontrolled infections.I have another cancer besides skin or in situ cervical cancer that needs treatment.I have a confirmed active fungal infection.I have a history of significant brain or nervous system conditions.My leukemia is newly diagnosed and fits specific WHO criteria.My AML is linked to specific genetic changes related to MDS.My kidney function is within the required range.My AML developed from a previous MDS or MDS/MPN condition.I can receive specific treatments for high white blood cell count before starting the study.
Research Study Groups:
This trial has the following groups:- Group 1: CPX-351 and Glasdegib
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
Has the federal government given authorization for CPX-351?
"Due to the absence of evidence proving efficacy, CPX-351's safety was rated 2 on our scale. However, there is some data that suggests it may be safe for use in patients."
Answered by AI
How many operational centers are currently running the trial?
"Patients can enrol for this clinical trial at 8 different sites, including the Moores Cancer Center and Chao Family Comprehensive Cancer Center. Additionally, there are 4 additional locations in California; University of California San Diego La Jolla, University of California Irvine Orange and University of California San Francisco."
Answered by AI
Are there any additional studies that have explored the efficacy of CPX-351?
"At present, 267 clinical trials are examining the efficacy of CPX-351 and 68 currently occupy Phase 3. Of these studies, a few are based in New york City but ultimately span 12,460 sites around the world."
Answered by AI
Are new participants being accepted for this experiment?
"Affirmative, the information on clinicaltrials.gov demonstrates that this investigation is actively searching for volunteers. This medical trial was first presented to the public on February 19th 2020 and its parameters were most recently updated in November 30th 2022; it aspires to enlist thirty participants from four locations."
Answered by AI
How many participants are anticipated to join this clinical investigation?
"Affirmative. The clinical trial, which was posted on February 19th 2020 and most recently updated November 30th 2022 is recruiting participants as confirmed by the information found onclinicaltrials.gov . Specifically, this study seeks to enroll thirty individuals from four distinct medical locations."
Answered by AI
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