Study Comparing Standard Chemotherapy to CPX-351 and/or Gilteritinib for Newly Diagnosed Acute Myeloid Leukemia (AML) with or without FLT3 Mutations
Sponsor: Children's Oncology Group
ClinicalTrials ID:NCT04293562
This clinical trial is testing whether a new treatment using CPX-351 and/or gilteritinib is more effective than standard chemotherapy for patients with newly diagnosed acute myeloid leukemia (AML), with or without specific genetic changes called FLT3 mutations.
Patient Parameters
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Program Overview
This study is exploring whether a new treatment approach using CPX-351, a combination of chemotherapy drugs daunorubicin and cytarabine, and/or gilteritinib, a drug that targets specific genetic changes, can better treat patients with newly diagnosed acute myeloid leukemia (AML) compared to standard chemotherapy. The study aims to see if these treatments can improve survival and reduce heart-related side effects. It also looks at how these treatments affect patients with and without FLT3 mutations, which are changes in a gene that can make cancer cells grow.
Description
The main goal of this study is to compare how well patients with newly diagnosed acute myeloid leukemia (AML) do when treated with either standard chemotherapy or a new treatment using CPX-351 and/or gilteritinib. CPX-351 is a special form of chemotherapy that stays in the bone marrow longer and may cause fewer heart problems. Gilteritinib is a drug that targets specific genetic changes in cancer cells. The study will look at how these treatments affect survival, heart health, and the presence of cancer cells after treatment. Patients will be divided into groups based on their genetic test results and risk levels. The study will also explore how these treatments affect brain function and other health outcomes over time.
Eligibility Criteria
Inclusion Criteria
- Must be enrolled in a related screening study before joining this trial.
- Must be under 22 years old at the time of joining the study.
- Must have a new diagnosis of acute myeloid leukemia (AML) according to specific medical guidelines.
- Must have a certain percentage of cancer cells in the bone marrow or specific genetic changes related to AML.
- Must agree to use effective birth control during and after treatment if of childbearing potential.
- Must not have any known heart conditions that could affect treatment.
- Must be able to understand and agree to the study requirements, including signing a consent form.
Exclusion Criteria
- Cannot have certain genetic conditions or syndromes that increase the risk of treatment side effects.
- Cannot have other types of cancer or specific blood disorders.
- Cannot have received certain types of cancer treatments before joining the study.
- Cannot be pregnant or breastfeeding due to potential risks to the baby.
- Cannot have significant heart problems before starting the study.
- Cannot be taking certain medications that could interfere with the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| USA Health Strada Patient Care Center | 36604 | Mobile | Alabama |
| Banner Children's at Desert | 85202 | Mesa | Arizona |
| Phoenix Childrens Hospital | 85016 | Phoenix | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| Arkansas Children's Hospital | 72202-3591 | Little Rock | Arkansas |
| Kaiser Permanente Downey Medical Center | 90242 | Downey | California |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| Loma Linda University Medical Center | 92354 | Loma Linda | California |
| Miller Children's and Women's Hospital Long Beach | 90806 | Long Beach | California |
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