CPX-351 + Gilteritinib for Acute Myeloid Leukemia
Palo Alto (17 mi)Overseen byTodd M Cooper
Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Children's Oncology Group
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.
Eligibility Criteria
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.Treatment Details
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.
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.
CPX-351 is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as VYXEOS for:
- Newly-diagnosed therapy-related acute myeloid leukemia (t-AML)
- AML with myelodysplasia-related changes (AML-MRC)
🇪🇺 Approved in European Union as VYXEOS for:
- Newly-diagnosed therapy-related acute myeloid leukemia (t-AML)
- AML with myelodysplasia-related changes (AML-MRC)
Find a clinic near you
Research locations nearbySelect from list below to view details:
Lucile Packard Children's Hospital Stanford UniversityPalo Alto, CA
MedStar Georgetown University HospitalWashington, United States
Children's National Medical CenterWashington, United States
Palms West Radiation TherapyLoxahatchee Groves, FL
More Trial Locations
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Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
National Cancer Institute (NCI)Collaborator