# 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

> **NCT04293562** · PHASE3 · RECRUITING · sponsor: **Children's Oncology Group** · enrollment: 1186 (estimated)

## Conditions studied

- Acute Myeloid Leukemia

## Interventions

- **PROCEDURE:** Allogeneic Hematopoietic Stem Cell Transplantation
- **DRUG:** Asparaginase Erwinia chrysanthemi
- **PROCEDURE:** Biospecimen Collection
- **PROCEDURE:** Bone Marrow Aspiration
- **PROCEDURE:** Bone Marrow Biopsy
- **PROCEDURE:** Computed Tomography
- **DRUG:** Cytarabine
- **DRUG:** Daunorubicin Hydrochloride
- **DRUG:** Dexrazoxane Hydrochloride
- **DRUG:** Etoposide
- **OTHER:** Fludeoxyglucose F-18
- **DRUG:** Gemtuzumab Ozogamicin
- **DRUG:** Gilteritinib Fumarate
- **DRUG:** Liposome-encapsulated Daunorubicin-Cytarabine
- **PROCEDURE:** Magnetic Resonance Imaging
- **DRUG:** Methotrexate
- **DRUG:** Mitoxantrone Hydrochloride
- **PROCEDURE:** Positron Emission Tomography
- **OTHER:** Questionnaire Administration
- **DRUG:** Therapeutic Hydrocortisone

## Key facts

- **NCT ID:** NCT04293562
- **Lead sponsor:** Children's Oncology Group
- **Sponsor class:** NETWORK
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2020-07-21
- **Primary completion:** 2029-06-30
- **Final completion:** 2029-06-30
- **Target enrollment:** 1186 (ESTIMATED)
- **Last updated:** 2026-05-05

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04293562

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04293562, "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". Retrieved via AI Analytics 2026-07-08 from https://api.ai-analytics.org/clinical/NCT04293562. Licensed CC0.

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