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Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old

NCT00590837 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 459

Last updated 2014-04-02

No results posted yet for this study

Summary

A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5 + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in complete remission (CR) will then receive a post-remission schedule with or without lomustine according to randomization. Patients from 60 to 65 years old will be proposed to reduced conditioning allogeneic transplantation after first consolidation.

Conditions

Interventions

DRUG

Lomustine

Induction: chemotherapy + lomustine (CCNU), 200 mg/m2 orally at day 1. Consolidation: chemotherapy + lomustine (CCNU), 80 mg orally at day 1. Reinductions: chemotherapy + lomustine (CCNU), 40 mg orally at day 1.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Arnaud Pigneux, MD, PhD · University Hospital Bordeaux, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2012-12-31
Completion
2013-12-31

Countries

  • France

Study Locations

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Entities

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 NCT00590837 on ClinicalTrials.gov