drugset / Trial / NCT00548431
NOPHO ALL-2008 Pilot Study on Consolidation Therapy for Children and Adolescents With Acute Lymphoblastic Leukemia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | 25 mg/m2 | — |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | 75 mg/m2 | — |