Completed PHASE2 INTERVENTIONAL 1-arm NCT00416598

Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia

Phase II Study of Maintenance Therapy With Decitabine (NSC #127716) Following Standard Induction and Cytogenetic Risk-Adapted Intensification in Previously Untreated Patients With AML < 60 Years

Sponsor: National Cancer Institute (NCI)

Conditions Acute Myeloid Leukemia Acute Myeloid Leukemia With Myelodysplasia-Related Changes Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11 Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1 Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A Untreated Adult Acute Myeloid Leukemia

Interventions Autologous Bone Marrow Transplantation Autologous Hematopoietic Stem Cell Transplantation Busulfan Cytarabine Daunorubicin Hydrochloride Decitabine Etoposide Filgrastim Laboratory Biomarker Analysis Pharmacological Study

Updated 14 times since 2017 Last updated: Jan 29, 2019 Started: Nov 15, 2006 Primary completion: Jan 31, 2011 Completion: Dec 1, 2016

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

This PHASE2 trial investigates Acute Myeloid Leukemia and Acute Myeloid Leukemia With Myelodysplasia-Related Changes and is currently completed. National Cancer Institute (NCI) leads this study, which shows 14 recorded versions since 2006 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

14 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Mar 2019 — Jan 2021 [monthly]

Completed PHASE2

Status: Active Not Recruiting → Completed

▶ Show 9 earlier versions

Jan 2019 — Mar 2019 [monthly]

Active Not Recruiting PHASE2
Sep 2018 — Jan 2019 [monthly]

Active Not Recruiting PHASE2
Jun 2018 — Sep 2018 [monthly]

Active Not Recruiting PHASE2
Dec 2017 — Jun 2018 [monthly]

Active Not Recruiting PHASE2
Oct 2017 — Dec 2017 [monthly]

Active Not Recruiting PHASE2
Jul 2017 — Oct 2017 [monthly]

Active Not Recruiting PHASE2
Apr 2017 — Jul 2017 [monthly]

Active Not Recruiting PHASE2
Feb 2017 — Apr 2017 [monthly]

Active Not Recruiting PHASE2
Jan 2017 — Feb 2017 [monthly]

Active Not Recruiting PHASE2

First recorded

Nov 2006

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

National Cancer Institute (NCI)

Data source: National Cancer Institute (NCI)

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

Study Locations

Atlanta, United States , Baltimore, United States , Bangor, United States , Berlin Corners, United States , Bethesda, United States , Boston, United States , Buffalo, United States , Burlington, United States , Camden, United States , Chapel Hill, United States and 28 more locations