A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations

Summary

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.

Conditions

• Acute Myeloid Leukemia

Interventions

DRUG

Liposome-encapsulated Daunorubicin-Cytarabine

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Methotrexate

Given IT

DRUG

Mitoxantrone Hydrochloride

Given IV

PROCEDURE

Positron Emission Tomography

Undergo FDG-PET

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Therapeutic Hydrocortisone

Given IT

DRUG

Gilteritinib Fumarate

Given PO/NG/G-tube

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic HSCT

DRUG

Asparaginase Erwinia chrysanthemi

Given IM or IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo BM aspiration

PROCEDURE

Bone Marrow Biopsy

BM biopsy

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cytarabine

Given IV or IT

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Dexrazoxane Hydrochloride

Given IV

DRUG

Etoposide

Given IV

OTHER

Fludeoxyglucose F-18

Undergo FDG-PET

DRUG

Gemtuzumab Ozogamicin

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Todd M Cooper · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-21

Primary Completion

2029-06-30

Completion

2029-06-30

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• Puerto Rico

Study Locations