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

> **NCT00416598** · PHASE2 · COMPLETED · sponsor: **National Cancer Institute (NCI)** · enrollment: 546 (actual)

## Conditions studied

- 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

- **PROCEDURE:** Autologous Bone Marrow Transplantation
- **PROCEDURE:** Autologous Hematopoietic Stem Cell Transplantation
- **DRUG:** Busulfan
- **DRUG:** Cytarabine
- **DRUG:** Daunorubicin Hydrochloride
- **DRUG:** Decitabine
- **DRUG:** Etoposide
- **BIOLOGICAL:** Filgrastim
- **OTHER:** Laboratory Biomarker Analysis
- **OTHER:** Pharmacological Study

## Key facts

- **NCT ID:** NCT00416598
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2006-11-15
- **Primary completion:** 2011-01-31
- **Final completion:** 2016-12-01
- **Target enrollment:** 546 (ACTUAL)
- **Last updated:** 2019-02-19


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00416598

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00416598, "Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT00416598. Licensed CC0.

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