drugset / Trial / NCT00548431

NOPHO ALL-2008 Pilot Study on Consolidation Therapy for Children and Adolescents With Acute Lymphoblastic Leukemia

NCT00548431

Phase 2 Completed 38 enrolled Rigshospitalet, Denmark
NaSingle-groupOpen-labelTreatment

Summary

The present pharmacokinetic (PK)-pharmacodynamic (PD) study will explore the toxicity and antileukemic response during the initial 3 months of individualised therapy of children and young adults with acute lymphoblastic leukemia (ALL). The investigators will on an individual toxicity-titrated basis attempt to increase the dose intensity of the 6-mercaptopurine used in the two-months post-remission treatment phase of lower risk childhood ALL. This will be performed together with continuous PEG-ASP (every 2nd week) and interspersed HD-MTX (5 g/m\^2) every 3rd week. Thus, the trial will also test the feasibility of this particular drug combination.

Timeline

Start
2007-12
Primary completion
2009-01
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Subject MERCAPTOPURINE ANHYDROUS Small molecule 25 mg/m2
Subject MERCAPTOPURINE ANHYDROUS Small molecule 75 mg/m2