Allopurinol in maintenance therapy of acute lymphoblastic leukemia in childhood

Optimizing 6-mercaptopurine therapy in pediatric acute lymphoblastic leukemia by using allopurinol. Clinical study in children 1-19 years on maintenance therapy for acute lymphoblastic leukemia.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003409-33-SE

Enrollment

Registered

2016-10-12

Start date

2016-12-09

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute lymphoblastic leukemia diagnosed at age 0-18 in children

Interventions

Trade Name: Allopurinol Teva Pharmaceutical Form: Tablet INN or Proposed INN: ALLOPURINOL CAS Number: 315-30-0 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 50 mg

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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);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	—

Measure

Time frame

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);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

—

Secondary

Measure	Time frame
Secondary end point(s): Liver toxicity (laboratory measures, ultrasonography) Incidence of hypoglycemia SAE;Timepoint(s) of evaluation of this end point: At week 24	—

Countries

Finland, Sweden

Contacts

Public ContactBarncancerforskningscentrum

Västra Götaland regionen

vobjab@gmail.com+46707695159

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026