Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm NCT02521493

Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome

Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome

Sponsor: Children's Oncology Group

Conditions Acute Myeloid Leukemia Down Syndrome Myelodysplastic Syndrome Myeloid Leukemia Associated With Down Syndrome Myeloproliferative Neoplasm

Interventions Asparaginase Asparaginase Erwinia chrysanthemi Cytarabine Daunorubicin Hydrochloride Etoposide Laboratory Biomarker Analysis Mitoxantrone Hydrochloride Thioguanine

Updated 38 times since 2017 Last updated: Jul 22, 2025 Started: Dec 23, 2015 Primary completion: Jun 30, 2024 Completion: Jun 30, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02521493, this PHASE3 trial focuses on Acute Myeloid Leukemia and Down Syndrome and remains ongoing. Sponsored by Children's Oncology Group, it has been updated 38 times since 2015, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

38 versions recorded

Sep 2025 — Present [monthly]

Active Not Recruiting PHASE3
Aug 2025 — Sep 2025 [monthly]

Active Not Recruiting PHASE3
Jul 2025 — Aug 2025 [monthly]

Active Not Recruiting PHASE3
Apr 2025 — Jul 2025 [monthly]

Active Not Recruiting PHASE3
Dec 2024 — Apr 2025 [monthly]

Active Not Recruiting PHASE3

▶ Show 33 earlier versions

Sep 2024 — Dec 2024 [monthly]

Active Not Recruiting PHASE3
Aug 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE3
Jul 2024 — Aug 2024 [monthly]

Active Not Recruiting PHASE3
Dec 2023 — Jul 2024 [monthly]

Active Not Recruiting PHASE3
May 2023 — Dec 2023 [monthly]

Active Not Recruiting PHASE3
Apr 2023 — May 2023 [monthly]

Active Not Recruiting PHASE3
Feb 2023 — Apr 2023 [monthly]

Active Not Recruiting PHASE3
Nov 2022 — Feb 2023 [monthly]

Active Not Recruiting PHASE3
Sep 2022 — Nov 2022 [monthly]

Active Not Recruiting PHASE3
Jul 2022 — Sep 2022 [monthly]

Active Not Recruiting PHASE3
Jun 2022 — Jul 2022 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
May 2022 — Jun 2022 [monthly]

Recruiting PHASE3
Apr 2022 — May 2022 [monthly]

Recruiting PHASE3
Mar 2022 — Apr 2022 [monthly]

Recruiting PHASE3
Nov 2021 — Mar 2022 [monthly]

Recruiting PHASE3
Sep 2021 — Nov 2021 [monthly]

Recruiting PHASE3
Jun 2021 — Sep 2021 [monthly]

Recruiting PHASE3
Apr 2021 — Jun 2021 [monthly]

Recruiting PHASE3
Feb 2021 — Apr 2021 [monthly]

Recruiting PHASE3
Jan 2021 — Feb 2021 [monthly]

Recruiting PHASE3
Oct 2020 — Jan 2021 [monthly]

Recruiting PHASE3
Sep 2020 — Oct 2020 [monthly]

Recruiting PHASE3
Jul 2020 — Sep 2020 [monthly]

Recruiting PHASE3
May 2020 — Jul 2020 [monthly]

Recruiting PHASE3
Apr 2020 — May 2020 [monthly]

Recruiting PHASE3
Nov 2019 — Apr 2020 [monthly]

Recruiting PHASE3
Oct 2019 — Nov 2019 [monthly]

Recruiting PHASE3
Jul 2019 — Oct 2019 [monthly]

Recruiting PHASE3
Apr 2019 — Jul 2019 [monthly]

Recruiting PHASE3
Sep 2018 — Apr 2019 [monthly]

Recruiting PHASE3
Jun 2018 — Sep 2018 [monthly]

Recruiting PHASE3
Feb 2017 — Jun 2018 [monthly]

Recruiting PHASE3
Jan 2017 — Feb 2017 [monthly]

Recruiting PHASE3

First recorded

Dec 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Children's Oncology Group
National Cancer Institute (NCI)

Data source: Children's Oncology Group

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Akron, United States , Albany, United States , Albuquerque, United States , Amarillo, United States , Anchorage, United States , Ann Arbor, United States , Asheville, United States , Atlanta, United States , Aurora, United States , Austin, United States and 139 more locations