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Anti-tumor antibiotic, Anti-metabolites
Ruxolitinib + CPX-351 for Acute Myeloid Leukemia
Phase 1 & 2
Recruiting
Led By Ronan T Swords
Research Sponsored by Uma Borate
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Participants eligible for this study have either MPN in accelerated phase (AP) or blast phase (BP), defined as:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date of first documented response (alr-c) to date of documented relapse, up to 2 years
Awards & highlights
Study Summary
This trial is testing the combination of two drugs, ruxolitinib and CPX-351, to treat patients with a specific type of leukemia.
Who is the study for?
This trial is for patients with advanced myeloproliferative neoplasms, including those previously diagnosed with conditions like polycythemia vera or essential thrombocythemia. Participants must be able to perform daily activities (ECOG status 0-2), have a heart function within normal limits, and agree to use contraception. Exclusions include ongoing participation in another clinical trial, certain leukemia types, uncontrolled infections or illnesses, known drug hypersensitivity, and recent surgery.Check my eligibility
What is being tested?
The study is testing the combination of Ruxolitinib (a drug that blocks enzymes needed for cancer cell growth) with CPX-351 (chemotherapy encapsulated in fat particles designed to better target cancer cells). The goal is to determine the best dose and effectiveness of this combination treatment for secondary acute myeloid leukemia compared to CPX-351 alone.See study design
What are the potential side effects?
Potential side effects may include risks associated with chemotherapy such as nausea, fatigue, increased risk of infection due to low blood counts; organ inflammation from Ruxolitinib; allergic reactions; liver issues indicated by elevated bilirubin levels; and digestive disturbances.
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 condition is in the accelerated or blast phase.
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My blood or bone marrow has 10% to 19% blast cells.
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I was previously diagnosed with PV, ET, or PMF.
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I am eligible for strong chemotherapy to start my cancer treatment.
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My kidney function, measured by creatinine or filtration rate, is within the required range.
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My blood levels of potassium, magnesium, and calcium are normal or can be normalized with supplements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ date of first documented response (alr-c) to date of documented relapse, up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of first documented response (alr-c) to date of documented relapse, 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
Dose limiting toxicity (DLT) (Phase I)
Proportion of participants that achieve at least an Acute Leukemia Response-Partial response (>= ALR-P, per 2012 myeloproliferative neoplasm - blast phase [MPN-BP] criteria) (Phase 2)
Secondary outcome measures
Event-free survival (EFS)
Incidence of adverse events as assessed by CTCAE version 5.0
Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
+4 moreOther outcome measures
Frequency of each mutation (single nucleotide polymorphism [SNP])
Proportion of participants that achieve at least a complete remission with incomplete marrow recovery (CRi) (per European Leukemia Net [ELN] criteria)
Proportion of participants who have an MRD negative status
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (CPX-351, ruxolitinib, allogeneic SCT)Experimental Treatment3 Interventions
See Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liposome-encapsulated Daunorubicin-Cytarabine
2016
Completed Phase 2
~100
Ruxolitinib
2018
Completed Phase 3
~1140
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Find a Location
Who is running the clinical trial?
Uma BorateLead Sponsor
5 Previous Clinical Trials
198 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,312 Total Patients Enrolled
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood levels of potassium, magnesium, and calcium are normal or can be normalized with supplements.I don't have lasting side effects from cancer treatment worse than mild.I do not have any untreated or uncontrolled infections.My leukemia has spread to my brain or spinal cord.I have not fully recovered from recent surgery, except for minor procedures like getting a port for chemotherapy.My disease is quickly worsening, or my organs are too weak for treatment.I am allergic to ruxolitinib, cytarabine, daunorubicin, or liposomal products.I will stop taking blood thinners before starting the study drug.I can take care of myself and am up and about more than half of my waking hours.I was previously diagnosed with PV, ET, or PMF.I am a man who will avoid fathering children or donate sperm during and up to 90 days after the study.I am willing to take pills for treatment.I have ET, PV, or MF and have been treated with specific therapies for these conditions.I have been stable and fever-free for over 72 hours while on infection treatment.I do not have any serious illnesses that could make the trial unsafe for me.I have a blood clotting disorder with active bleeding or signs of clotting.I have received a high dose of a specific chemotherapy drug.My leukemia affects my blood or bone marrow.I haven't taken any experimental drugs recently or am not currently in another drug study.I have a history of Wilson's disease or a similar copper metabolism disorder.I am eligible for strong chemotherapy to start my cancer treatment.I have a specific type of leukemia (FAB M3).My blood or bone marrow has 10% to 19% blast cells.My kidney function, measured by creatinine or filtration rate, is within the required range.My condition is in the accelerated or blast phase.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CPX-351, ruxolitinib, allogeneic SCT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
To date, how many people have signed up for this research project?
"Yes, the information available on clinicaltrials.gov affirms that this study is still enrolling patients. This particular trial was first posted on February 20th, 2019 and was last updated on May 17th, 2022. The research team conducting this experiment needs to recruit 47 individuals from 3 separate locations."
Answered by AI
What is the point of this medical study?
"This clinical trial, sponsored by Incyte Corporation, will primarily be measuring the occurrence of dose-limiting toxicity (DLT) during the treatment period. This will be done through assessment of data collected over a 28-day cycle. Additionally, this trial will also be looking at secondary outcomes such as remission duration, relapse-free survival, and event-free survival. These latter measures will be calculated using time-to-event analysis methods such as Kaplan-Meier curves or cumulative incidence curves."
Answered by AI
Are there any other medical studies that have used Liposome-encapsulated Daunorubicin-Cytarabine?
"There are currently 370 active medical studies for Liposome-encapsulated Daunorubicin-Cytarabine with 79 of those trials in Phase 3. While New york, New York has a significant concentration of these clinical trials, there are actually 15550 locations running these sorts of tests."
Answered by AI
What are the common indications for Liposome-encapsulated Daunorubicin-Cytarabine?
"Daunorubicin-Cytarabine, which is encapsulated by liposomes, is a popular treatment for meningeal leukemia. This method can also be used to ameliorate symptoms for patients suffering from leukemia, myelocytic, acute, blast phase chronic myelocytic leukemia, lymphoma."
Answered by AI
Are there any open slots left for this research project?
"That is correct, the listing on clinicaltrials.gov says that this trial is open for enrollment. This particular research project was initially posted on February 20th, 2019 and has since been edited on May 17th, 2022. Currently, they are looking to enroll 47 patients from 3 different locations."
Answered by AI
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