# 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

Source: https://onco.cc/trials/nct04293562/  
OnCo record `nct04293562` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Crisantaspase, Asparaginase, Cytarabine, Daunorubicin, Dexrazoxane, Etoposide, Fludeoxyglucose F-18, Gemtuzumab ozogamicin, Gilteritinib, CPX-351, Methotrexate and Mitoxantrone in Acute myeloid leukaemia, run by Children's Oncology Group, now recruiting.

## Summary

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 is a phase 3 interventional study registered as NCT04293562 by Children's Oncology Group, with 1400 participants planned, started 2020-07-21 and due to reach its primary completion in 2029-06-30. Interventions recorded: Allogeneic Hematopoietic Stem Cell Transplantation, Asparaginase Erwinia chrysanthemi, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cytarabine, Daunorubicin Hydrochloride, Dexrazoxane Hydrochloride, Etoposide, Fludeoxyglucose F-18, Gemtuzumab Ozogamicin, Gilteritinib Fumarate, Liposome-encapsulated Daunorubicin-Cytarabine, Magnetic Resonance Imaging, Methotrexate, Mitoxantrone Hydrochloride, Positron Emission Tomography, Questionnaire Administration, Therapeutic Hydrocortisone. Conditions recorded: Acute Myeloid Leukemia.

Linked to the drug Crisantaspase because the registry names it among its interventions and Acute myeloid leukaemia among its conditions. Registry record only: no result has been read by an editor.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-22
- Tags: pipeline; ctgov-ingest
- Registry id: NCT04293562
- Phase: 3
- Setting: A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations
- Sponsor: Children's Oncology Group
- Enrolled: 1400

## Sources

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

## Connected records

- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/)
- drugs: [Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase)](https://onco.cc/drugs/asparaginase/), [CPX-351 (liposomal daunorubicin-cytarabine)](https://onco.cc/drugs/cpx-351/), [Crisantaspase (recombinant Erwinia asparaginase)](https://onco.cc/drugs/crisantaspase/), [Cytarabine](https://onco.cc/drugs/cytarabine/), [Daunorubicin](https://onco.cc/drugs/daunorubicin/), [Dexrazoxane](https://onco.cc/drugs/dexrazoxane/), [Etoposide](https://onco.cc/drugs/etoposide/), [Fludeoxyglucose F-18 (FDG)](https://onco.cc/drugs/fludeoxyglucose-f18/), [Gemtuzumab ozogamicin](https://onco.cc/drugs/gemtuzumab-ozogamicin/), [Gilteritinib](https://onco.cc/drugs/gilteritinib/), [Methotrexate](https://onco.cc/drugs/methotrexate/), [Mitoxantrone](https://onco.cc/drugs/mitoxantrone/)

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