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ACTIVE NOT RECRUITING
NCT01627041
PHASE2

Decitabine, Cytarabine, and Daunorubicin Hydrochloride in Treating Patients With Acute Myeloid Leukemia

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This randomized phase II trial studies how well decitabine works when given together with daunorubicin hydrochloride and cytarabine in treating patients with acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, daunorubicin hydrochloride, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Decitabine may help daunorubicin hydrochloride and cytarabine kill more cancer cells by making them more sensitive to the drugs. It is not yet known whether low-dose decitabine is more effective than high-dose decitabine when giving together with daunorubicin hydrochloride and cytarabine in treating acute myeloid leukemia.

Official title: Randomized Phase II Study of Epigenetic Priming Using Decitabine With Induction Chemotherapy in Patients With Acute Myelogenous Leukemia (AML)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

178

Start Date

2011-09-16

Completion Date

2027-02-01

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

Cytarabine

Given IV

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Decitabine

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

Locations (9)

Lafayette Family Cancer Center-EMMC

Brewer, Maine, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

NYP/Weill Cornell Medical Center

New York, New York, United States

Montefiore Medical Center-Weiler Hospital

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Case Western Reserve University

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States