drugset / Trial / NCT03022747

Optimizing 6-mercaptopurine Therapy in Pediatric Acute Lymphoblastic Leukemia by Using Allopurinol

NCT03022747

Phase 2 Unknown 60 enrolled Vastra Gotaland Region
Non-randomizedCrossoverOpen-labelTreatment

Summary

The study will investigate, in children with acute lymphoblastic leukemia during maintenance treatment, if addition of allopurinol to conventional oral 6-mercaptopurine and methotrexate therapy, affects erythrocyte concentrations of 6-thioguanine and 6 methylmercaptopurine. The effect on hematological and liver toxicity parameters in blood will also be investigated as well as clinical toxicity.

Timeline

Start
2017-01
Primary completion
2018-12
Completion
2019-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Allopurinol Small molecule 50 mg/m2
Subject Allopurinol Small molecule 100 mg/m2
Comparator MERCAPTOPURINE ANHYDROUS Small molecule Oral
Comparator Methotrexate Small molecule Oral