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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
No Placebo-Only Group
Pivotal Trial

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-free survival (EFS)
Secondary study objectives
Incidence of adverse events
Overall survival (OS)
Proportion of patients positive for minimal residual disease (MRD+)
+3 more
Other study objectives
Course duration
Length of hospitalization
Time to count recovery

Awards & Highlights

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.

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
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Etoposide
2010
Completed Phase 3
~2960
Methotrexate
2019
Completed Phase 4
~4400
Liposome-encapsulated Daunorubicin-Cytarabine
2017
Completed Phase 2
~170
Gemtuzumab Ozogamicin
2006
Completed Phase 4
~460
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1240
Cogstate Assessment Battery
2020
Completed Early Phase 1
~20
Mitoxantrone Hydrochloride
2016
Completed Phase 3
~650
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Computed Tomography
2017
Completed Phase 2
~2790
Cytarabine
2016
Completed Phase 3
~3330
Asparaginase
2005
Completed Phase 4
~5220
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5330
Dexrazoxane Hydrochloride
2013
Completed Phase 1
~50
Biospecimen Collection
2004
Completed Phase 3
~2030
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Positron Emission Tomography
2011
Completed Phase 2
~2200
Therapeutic Hydrocortisone
2012
Completed Phase 3
~560

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
460 Previous Clinical Trials
238,598 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,016,739 Total Patients Enrolled
Todd M CooperPrincipal InvestigatorChildren's Oncology Group
2 Previous Clinical Trials
998 Total Patients Enrolled

Media Library

CPX-351 (Liposomal Anthracycline and Cytarabine) Clinical Trial Eligibility Overview. Trial Name: NCT04293562 — Phase 3
Acute Myeloid Leukemia Research Study Groups: Arm A High Risk Group, Arm A Low Risk Group 2, Arm AC Low Risk Group 2, Arm BC High Risk Group, Arm AC High Risk Group, Arm AD High Risk Group, Arm B High Risk Group, Arm AD Low Risk Group 2, Arm BD High Risk Group, Arm A Low Risk Group 1, Arm B Low Risk Group 1, Arm B Low Risk Group 2, Arm BD Low Risk Group 2, Arm BC Low Risk Group 2
Acute Myeloid Leukemia Clinical Trial 2023: CPX-351 Highlights & Side Effects. Trial Name: NCT04293562 — Phase 3
CPX-351 (Liposomal Anthracycline and Cytarabine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04293562 — Phase 3
~553 spots leftby Sep 2027
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