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Randomized induction and post induction therapy in adult patients (= 1.5.

Completed
Conditions
Acute myelocytic leukemia, RAEB, RAEB-t.
Registration Number
NL-OMON25506
Lead Sponsor
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl
Brief Summary

J Clin Oncol. 2007 Jan 1;25(1):1-2. Epub 2006 Dec 4.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
800
Inclusion Criteria

1. Age 18-60 years (incl.);

2. Subjects with a cytopathologically.

Exclusion Criteria

1. Prior chemotherapy within 6 months of study entry;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Endpoint for the comparison of induction treatment arm B with arm A and for the comparison yes or no G-CSF priming:<br /><br>1. Event-free survival (i.e., time from registration to induction failure, death or relapse whichever occurs first); the time to failure of patients with induction failure is set at one day.<br /><br><br /><br /><br>Endpoint for the comparison of PBSCT with cycle III:<br /><br>1. Disease-free survival measured from the date of second randomization to relapse or death from any cause.<br /><br><br /><br /><br>Endpoint for the evaluation of Allo SCT:<br /><br>1. Disease-free survival measured from the date of Allo SCT to relapse or death from any cause.
Secondary Outcome Measures
NameTimeMethod
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