drugset / Trial / NCT01366898

Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph 'Negative in Elderly Patients (> 55 Years)

NCT01366898

Phase 4 Unknown 100 enrolled PETHEMA Foundation
NaSingle-groupOpen-labelTreatment

Summary

The protocol objective is providing adequate treatment and based on broad consensus in elderly patients with Acute Lymphoblastic Leukemia (ALL). Apply uniform treatment that enables a joint analysis of results strong enough to make conclusions on specific subgroups of patients (genotypic subtypes, particularly LAL Bcr/abl positive, phenotype, or strata of age or associated diseases). Provide results of a treatment to consider standard against which to compare the results of phase II trials of experimental drugs that undoubtedly will be activated in the coming years

Timeline

Start
2007-06-30
Primary completion
2022-12
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 1000 mg/m2
Subject Dexamethasone Small molecule 10 mg/m2
Subject Idarubicin Small molecule 10 mg
Subject Methotrexate Small molecule 1000 mg/m2 Intrathecal