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Liposomal Anthracycline and Cytarabine
CPX-351 + Gilteritinib for Acute Myeloid Leukemia
Phase 3
Waitlist Available
Led By Todd M Cooper
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing whether a new combination of drugs (CPX-351 and gilteritinib) is more effective than standard chemotherapy for patients with newly diagnosed acute myeloid leukemia.
Who is the study for?
This trial is for patients under 22 years old newly diagnosed with acute myeloid leukemia (AML), either with or without FLT3 gene mutations. They must have certain levels of cancer cells in their blood or bone marrow and agree to use contraception if of reproductive potential. Excluded are those with specific genetic syndromes, prior significant cancer treatments, pregnant or breastfeeding women, and those not using effective contraception.Check my eligibility
What is being tested?
The study compares standard chemotherapy against therapy combining CPX-351 (liposome-encapsulated daunorubicin-cytarabine) and/or gilteritinib in AML patients. It aims to see if these new therapies are more effective or cause fewer heart problems than traditional treatments, especially for those with FLT3 mutations.See study design
What are the potential side effects?
Potential side effects include damage to the heart muscle, low blood cell counts leading to increased infection risk, bleeding complications, nausea and vomiting from chemotherapy drugs. Gilteritinib may also cause changes in heartbeat rhythm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free survival (EFS)
Secondary outcome measures
Incidence of adverse events
Overall survival (OS)
Proportion of patients positive for minimal residual disease (MRD+)
+3 moreOther outcome measures
Course duration
Length of hospitalization
Time to count recovery
Trial Design
14Treatment groups
Experimental Treatment
Group I: Arm BD Low Risk Group 2Experimental Treatment19 Interventions
Arm BD Low Risk Group 2: See Detailed Description.
Group II: Arm BD High Risk GroupExperimental Treatment16 Interventions
Arm BD High Risk Group: See Detailed Description.
Group III: Arm BC Low Risk Group 2Experimental Treatment19 Interventions
Arm BC Low Risk Group 2: See Detailed Description.
Group IV: Arm BC High Risk GroupExperimental Treatment16 Interventions
Arm BC High Risk Group: See Detailed Description.
Group V: Arm B Low Risk Group 2Experimental Treatment16 Interventions
Arm B Low Risk Group 2: See Detailed Description.
Group VI: Arm B Low Risk Group 1Experimental Treatment16 Interventions
Arm B Low Risk Group 1: See Detailed Description.
Group VII: Arm B High Risk GroupExperimental Treatment15 Interventions
Arm B High Risk Group: See Detailed Description.
Group VIII: Arm AD Low Risk Group 2Experimental Treatment19 Interventions
Arm AD Low Risk Group 2: See Detailed Description.
Group IX: Arm AD High Risk GroupExperimental Treatment17 Interventions
Arm AD High Risk Group: See Detailed Description.
Group X: Arm AC Low Risk Group 2Experimental Treatment19 Interventions
Arm AC Low Risk Group 2: See Detailed Description.
Group XI: Arm AC High Risk GroupExperimental Treatment17 Interventions
Arm AC High Risk Group: See Detailed Description.
Group XII: Arm A Low Risk Group 2Experimental Treatment18 Interventions
Arm A Low Risk Group 2: See Detailed Description.
Group XIII: Arm A Low Risk Group 1Experimental Treatment17 Interventions
Arm A Low Risk Group 1: See Detailed Description.
Group XIV: Arm A High Risk GroupExperimental Treatment16 Interventions
Arm A High Risk Group: See Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Therapeutic Hydrocortisone
2012
Completed Phase 3
~340
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Positron Emission Tomography
2008
Completed Phase 2
~2240
Cytarabine
2016
Completed Phase 3
~3310
Biospecimen Collection
2004
Completed Phase 2
~1730
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Methotrexate
2013
Completed Phase 4
~3800
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Etoposide
2010
Completed Phase 3
~2440
Gemtuzumab Ozogamicin
2006
Completed Phase 4
~440
Liposome-encapsulated Daunorubicin-Cytarabine
2016
Completed Phase 2
~100
Dexrazoxane Hydrochloride
2013
Completed Phase 1
~50
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5070
Mitoxantrone Hydrochloride
2016
Completed Phase 3
~650
Asparaginase
2005
Completed Phase 4
~5000
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
454 Previous Clinical Trials
236,540 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,923,089 Total Patients Enrolled
Todd M CooperPrincipal InvestigatorChildren's Oncology Group
2 Previous Clinical Trials
998 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at least 5 years old.I am currently pregnant.I do not have a genetic heart rhythm disorder or congenital heart block.I have been recently diagnosed with a type of leukemia called AML.I have been diagnosed with Shwachman Diamond syndrome.I have a telomere disorder.I have another type of cancer at the same time.My leukemia developed from a previous blood disorder.You do not have significant issues with your vision or motor skills that would stop you from using a computer or understanding visual tests.My doctor suspects I have a genetic risk that makes AML therapy more risky for me.I have Down syndrome.I have ongoing heart problems.My cancer has a specific FLT3 mutation as identified by Foundation Medicine.My leukemia is Philadelphia chromosome positive.I have been diagnosed with acute promyelocytic leukemia.I do not have a genetic heart rhythm condition or a congenital heart block.My bone marrow test shows I have AML with specific genetic features.I am under 22 years old.I have a blood disorder related to previous cancer treatment.I have not had cancer treatment except as specified.I am at least 2 years old at the time of my late callback.I speak English, French, or Spanish.I have Fanconi anemia.I have been diagnosed with juvenile myelomonocytic leukemia.I have been diagnosed with mixed phenotype acute leukemia.My cancer has a specific genetic feature (FLT3/ITD ratio > 0.1).I will use effective birth control during and for 6 months after my treatment.I am a man who can father children and will use birth control during and for 4 months after treatment.I am at least 2 years old at the time of the late callback.I have never been diagnosed with a neurodevelopmental disorder before my AML diagnosis.I am a man who can father children and will use birth control during and for 4 months after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A High Risk Group
- Group 2: Arm A Low Risk Group 2
- Group 3: Arm AC Low Risk Group 2
- Group 4: Arm BC High Risk Group
- Group 5: Arm AC High Risk Group
- Group 6: Arm AD High Risk Group
- Group 7: Arm B High Risk Group
- Group 8: Arm AD Low Risk Group 2
- Group 9: Arm BD High Risk Group
- Group 10: Arm A Low Risk Group 1
- Group 11: Arm B Low Risk Group 1
- Group 12: Arm B Low Risk Group 2
- Group 13: Arm BD Low Risk Group 2
- Group 14: Arm BC Low Risk Group 2
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Are people with the required qualifications able to participate in this experiment right now?
"The latest information from clinicaltrials.gov indicates that this trial is currently seeking participants. The listing was first posted on July 20th, 2020 and updated most recently on April 28th, 2022."
Answered by AI
What other medical research studies have there been on Arm AC Low Risk Group 2?
"The arm AC Low Risk Group was first observed in a 1995 study done at the National Institutes of Health Clinical Center. Out of the 1779 completed studies, 824 are currently recruiting patients with many trials being based in Kansas City, Missouri."
Answered by AI
In how many different places is this trial taking place?
"Children's Mercy Hospitals and Clinics in Kansas City, Missouri is one of several hospitals enrolling patients for this clinical trial. In addition to the aforementioned location, there are also 100 other sites where recruitment is taking place, such as Cardinal Glennon Children's Medical Center in Saint Louis, Iowa and Columbia Regional in Columbia, Massachusetts."
Answered by AI
Has the FDA given its blessing to Arm AC Low Risk Group 2?
"Arm AC Low Risk Group 2 has been studied enough that there is now data to support its efficacy. Furthermore, because this is a Phase 3 trial, there are multiple rounds of safety data supporting Arm AC Low Risk Group 2's use."
Answered by AI
What are doctors suggesting Arm AC Low Risk Group 2 for mostly?
"Arm AC Low Risk Group 2 can be used to administer amino acid supplementation therapy, merkel cell cancer treatment, and synovitis management."
Answered by AI
How many people are chosen to take part in this test group?
"Yes, this is an ongoing study that was first posted on July 20th 2020. The last update to the listing was on April 28th 2022. They are looking for a total of 1400 patients across 100 different sites."
Answered by AI
Who else is applying?
What site did they apply to?
Centre Hospitalier Universitaire de Quebec
What portion of applicants met pre-screening criteria?
Did not meet criteria
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