Allopurinol in maintenance therapy of acute lymphoblastic leukemia in childhood

Phase 1

• Conditions: Acute lymphoblastic leukemia diagnosed at age 0-18 in children; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003409-33-SE
• Lead Sponsor: Västra Götaland Regionen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-12
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

Children with acute lymphoblastic leukemia who have completed intensive chemotherapy and have started on maintenance therapy fulfilling criteria below
•Treatment according to NOPHO ALL2008 based protocols
•Age 0-18y at time of initial diagnosis
•TPMT wild type
•Written informed consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 75
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Mature B cell lymphoblastic leukemia
•t(9;22) positive acute lymphoblastic leukemia
•Unknown TPMT status or presence of TPMT mutation (both heterozygous and homozygous)
•Known intolerance to any of the chemotherapeutic drugs in the protocol.
•Major organ failure precluding administration of planned chemotherapy.
•Lactating female or female of childbearing potential not using adequate contraception.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Metabolite levels of 6-thioguanine and 6-methylmercaptopurine;Timepoint(s) of evaluation of this end point: At week 24 of the study;Main Objective: The objective of the trial is to investigate if addition of allopurinol during maintenance therapy of acute lymphoblastic leukemia can modify the metabolism of 6-mercaptopurine leading to a more favorable ratio of the mercaptopurin metabolites 6-thioguanine and 6-methylmercaptopurine;Secondary Objective: To investigate if an increased ratio of 6-thioguanine to 6-methylmercaptopurine leads to decreased toxicity (liver and metabolic)

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Liver toxicity (laboratory measures, ultrasonography)<br> Incidence of hypoglycemia<br> SAE<br> ;Timepoint(s) of evaluation of this end point: At week 24