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Treatment of Children and Adolescents With Refractory or Relapsed Acute Myeloid Leukemia

NCT00186966 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2011-04-06

No results posted yet for this study

Summary

This is an international multicenter open label randomized phase III trial in children with relapsed and refractory acute myeloid leukemia (AML) such a disease. The main purpose of this study is to determine the efficacy and toxicity of liposomal daunorubicin when added to fludarabine, ara-C and G-CSF(FLAG) in children with relapsed and refractory AML.

Conditions

Interventions

DRUG

Fludarabine, Cytarabine, Liposomal daunorubicin (DaunoXome)

See Detailed Description section for details of treatment interventions.

DRUG

Etoposide, Thioguanine, Cyclophosphamide, Busulfan, Melphalan

See Detailed Description section for details of treatment interventions.

PROCEDURE

Hematopoietic stem cell transplant

See Detailed Description section for details of treatment interventions.

RADIATION

Total body irradiation

See Detailed Description section for details of treatment interventions.

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Rubnitz, M.D. · St. Jude Children's Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2009-04-30
Completion
2010-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00186966 on ClinicalTrials.gov