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

NCT00416598 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 546

Last updated 2019-02-19

Study results available
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Summary

This phase II trial is studying the side effects and how well decitabine works when given as maintenance therapy after standard therapy in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine, daunorubicin, etoposide, busulfan, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving decitabine as maintenance therapy after standard therapy may keep cancer cells from coming back.

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

PROCEDURE

Autologous Bone Marrow Transplantation

Undergo autologous bone marrow transplantation

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous PBSC transplantation

DRUG

Busulfan

Given IV

DRUG

Cytarabine

Given IV

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Decitabine

Given IV

DRUG

Etoposide

Given IV

BIOLOGICAL

Filgrastim

Given SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • William Blum · Alliance for Clinical Trials in Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-15
Primary Completion
2011-01-31
Completion
2016-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00416598 on ClinicalTrials.gov