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A Risk-Oriented Therapeutic Strategy for Adult Acute Myelogenous Leukemia

NCT00400673 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 581

Last updated 2011-04-01

No results posted yet for this study

Summary

The study was set up to assess:

1. A two-step, increasing-intensity remission induction phase. A conventional chemotherapy course (ICE, plus G-CSF) was followed, in unresponsive patients, by sequential high-dose cytarabine (plus G-CSF), aiming to provide an early effective rescue to as many refractory cases as possible.
2. A risk-oriented postremission consolidation phase. The objective was to adopt allogeneic stem cell transplantation (alloSCT) in high-risk (HR) cases, while standard-risk (SR) ones were consolidated with a multicycle high-dose cytarabine-containing program, which included the use of autologous stem cells plus G-CSF to limit drug-related toxicity and intercycle treatment delays.

Conditions

  • Acute Myelogenous Leukemia

Interventions

BEHAVIORAL

Two-step remission induction and risk-oriented consolidation

Sponsors & Collaborators

  • Northern Italy Leukemia Group

    lead OTHER

Principal Investigators

  • Renato Bassan, MD · Ospedali Riuniti di Bergamo USC Ematologia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2000-05-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • Italy

Study Locations

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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 NCT00400673 on ClinicalTrials.gov