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Anti-tumor antibiotic
Vyxeos for Acute Myeloid Leukemia
Phase 1 & 2
Recruiting
Led By Gregory K Behbehani, MD, PhD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) functional status of 0, 1, or 2
Normal left ventricular ejection fraction (>= 50% by echocardiography or multi-gated acquisition radionuclide angiocardiography [MUGA]) and lifetime daunorubicin dose of less than 418 mg/m^2 (including recent course of 7+3)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing Vyxeos, a combination of two chemotherapy drugs, to see if it is effective and has fewer side effects than the standard treatment for acute myeloid leukemia.
Who is the study for?
This trial is for adults with acute myeloid leukemia who didn't respond to initial chemo. They must be fit enough for intensive treatment, have proper heart function and organ health, and not exceed a lifetime dose of certain chemo drugs. Participants need to use effective contraception and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests Vyxeos, a liposome-encapsulated combo of chemotherapy drugs cytarabine and daunorubicin, in patients whose leukemia persisted after standard treatment. It aims to see if this approach has fewer side effects while being more effective.See study design
What are the potential side effects?
Vyxeos may cause typical chemotherapy-related side effects such as fatigue, nausea, hair loss, increased risk of infection due to low blood cell counts, heart problems (rare), liver changes, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
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My heart pumps well and I've had limited exposure to a specific chemotherapy drug.
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My kidney function, measured by creatinine clearance or serum creatinine, is within the required range.
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I am a woman who can have children and agree to use two forms of birth control until 6 months after my last treatment dose. I also have a negative pregnancy test.
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I have been diagnosed with acute myeloid leukemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Calculation rate of complete response (CR) and complete response with incomplete hematologic recovery (CRi)
Incidence of adverse events
Secondary outcome measures
Overall survival
Progression-free survival
Other outcome measures
Efficacy of blast cell and leukemia stem/repopulating cell (LSC) elimination
Measurement of blast cell cycle fraction
Number of patients proceeding to stem cell transplantation following Vyxeos treatment
+1 moreSide effects data
From 2020 Phase 2 trial • 56 Patients • NCT0228672625%
Febrile Neutropenia
21%
Neutropenic Fever
17%
Lung Infection
17%
Sepsis
13%
Insomnia
8%
Infection
8%
Pericardial Effusion
8%
Hypertension
4%
Pancreatitis
4%
Intracranial Hemorrhage
4%
Cardiac Disorders
4%
Pleural Effusion
4%
Fever
4%
Joint Effusion
4%
Alanine aminotransferase Increase
4%
Anxiety
4%
Blood Bilirubin Increase
4%
Acute Coronary Syndrome
4%
Respiratory Failure
4%
Multi-Organ Failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (Intermediate-dose (75 Units/m^2) CPX-351)
Arm III (Standard-dose (100 Units/m^2) CPX-351)
Arm I (Lower-dose (50 Units/m^2) CPX-351)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (liposome-encapsulated daunorubicin-cytarabine)Experimental Treatment1 Intervention
Within 14-33 days after the start of previous cycle of chemotherapy, patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daunorubicin
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,413 Total Patients Enrolled
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,067 Total Patients Enrolled
Gregory K Behbehani, MD, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, can use effective birth control for 6 months, and won't breastfeed for 14 days after my last Vyxeos dose.I do not have any severe heart conditions or recent heart attacks.I have received a high dose of daunorubicin or similar drugs.I can take care of myself and am up and about more than half of my waking hours.My doctor thinks I won't fully recover without more treatment.My heart pumps well and I've had limited exposure to a specific chemotherapy drug.I haven't taken any experimental drugs recently or any side effects have mostly gone.My doctor thinks I can handle strong chemotherapy.I agree to use or have my partner use two forms of contraception and not donate sperm for 90 days after the last treatment dose.I've had specific chemo for AML and still have signs of cancer despite treatment.I have been diagnosed with acute promyelocytic leukemia.My doctor thinks I can't handle strong chemotherapy.My infection is under control.My AML is caused by a specific genetic change.My cancer has specific genetic changes related to TP53 or lacks p53 protein activity.My kidney function, measured by creatinine clearance or serum creatinine, is within the required range.I am not undergoing active treatment for another cancer, except for minor surgeries or hormone treatments.I do not have Wilson's disease or issues with copper metabolism.I am a woman who can have children and agree to use two forms of birth control until 6 months after my last treatment dose. I also have a negative pregnancy test.I have been diagnosed with acute myeloid leukemia.You have had a severe allergic reaction (grade 3 or higher) to cytarabine or daunorubicin in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (liposome-encapsulated daunorubicin-cytarabine)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Does the age limitation for this research extend beyond 25 years old?
"As per the entry requirements, this clinical trial is accessible to individuals aged 18-75. In contrast, there are 533 studies designed for minors and 1356 trials available to seniors."
Answered by AI
What criteria do participants have to meet in order to join this trial?
"This medical study is looking for 44 individuals between 18 and 75 years old with a diagnosis of acute myelogenous leukemia. For those hoping to join, these criteria must be met in order to qualify."
Answered by AI
Has there been any prior research conducted on Liposome-encapsulated Daunorubicin-Cytarabine?
"Currently, there are 254 active studies of Liposome-encapsulated Daunorubicin-Cytarabine with 62 trials at Phase 3. Primarily situated in New york City, this treatment is being tested and evaluated across 12276 locations worldwide."
Answered by AI
How many volunteers are currently participating in this trial?
"Affirmative. According to information hosted on clinicaltrials.gov, this medical research study is searching for participants as of the writing of this answer - it was posted in 2021 and last updated in 2023. 44 patients must be recruited from 2 different locations."
Answered by AI
Are there still openings available to participate in this trial?
"Clinicaltrials.gov informs us that this trial, which was created on the 29th of January 2021, is presently in search of participants. It has since been updated for the last time on June 1st 2023."
Answered by AI
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