Clinical study in children 1-19 years on maintenance therapy for acute lymphoblastic leukemia

Optimizing 6-mercaptopurine therapy in paediatric acute lymphoblastic leukemia by using allopurinol - Allopurinol in maintenance

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003409-33-FI

Enrollment

Registered

2018-05-16

Start date

2018-08-27

Completion date

Unknown

Last updated

2024-12-03

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

Conditions

Pediatric acute lymphoblastic leukemia

Interventions

Trade Name: Allonol, Apurin Sandoz, Zyloric Product Name: Allopurinol Product Code: Allopurinol Pharmaceutical Form: Tablet Other descriptive name: ALLOPURINOL

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All children with standard or intermediate risk acute lymphoblastic leukemia, aged 0-18 years at time of diagnosis of leukemia and treated according to ALL2008 protocols and with TPMT wild type who start maintenance 2 phase are eligible. Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 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 -Sever liver toxicity defined as persistent (= two weeks) elevation of either S-bilirubin > 50 ??mol/l or S-GPT > 20 x UNL (upper normal limit) or P-Protrombin complex > 1.5 -Reduced kidney function defined as S creatine = 2 x UNL -Lactating female or female of childbearing potential not using adequate contraception

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Secondary aims are to document how allopurinol affects laboratory parameters for hepatotoxicity and metabolic function after fasting.;Primary end point(s): The primary endpoint is the fraction of patients with &TG levels above 200 nmol/mmol Hb after 12 weeks of allopurinol treatment (week 25) vs. after 12 weeks of standard maintenance therapy.;Timepoint(s) of evaluation of this end point: Weeks 13 and 25;Main Objective: The aim of this study is to investigate if addition of allopurinol during maintenance therapy for acute lymphoblastic leukemia gives the same effects as in inflammatory bowel disease, i.e. higher 6-tioguaninen (6TG), lower 6-methylmercaptopurine and reduced hepatotoxicity. More specifically we will investigate if allopurinol increases the proportion of patients with 6TG levels above 200 nail/mmol Hb and reduces the proportion with 6MMP levels in excess of 15000 nail/mmol Hb.	—

Measure

Time frame

Secondary Objective: Secondary aims are to document how allopurinol affects laboratory parameters for hepatotoxicity and metabolic function after fasting.;Primary end point(s): The primary endpoint is the fraction of patients with &TG levels above 200 nmol/mmol Hb after 12 weeks of allopurinol treatment (week 25) vs. after 12 weeks of standard maintenance therapy.;Timepoint(s) of evaluation of this end point: Weeks 13 and 25;Main Objective: The aim of this study is to investigate if addition of allopurinol during maintenance therapy for acute lymphoblastic leukemia gives the same effects as in inflammatory bowel disease, i.e. higher 6-tioguaninen (6TG), lower 6-methylmercaptopurine and reduced hepatotoxicity. More specifically we will investigate if allopurinol increases the proportion of patients with 6TG levels above 200 nail/mmol Hb and reduces the proportion with 6MMP levels in excess of 15000 nail/mmol Hb.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints are to compare the following parameters with or without allopurinol treatment: -tThe mean level of 6TG and DNA-TGN at week 13 and 25 -The mean level of 6MMP at week 13 and 25 -The weighted mean level of Hb, WBC, platelets and ANC during the respective treatment phases -Laboratory measures of hepatotoxicity (weighed mean S-Bilirubin and S-GPT) during treatment phases -Laboratory measures of hypoglycaemia and metabolic dysfunction (cumulative incidence of hypoglycaemia during the treatment phases) -Serious adverse events (cumulative incidence during the treatment phases) -The mean cumulative doses of 6MP and Mix days with treatment interruption during the two treatment phases;Timepoint(s) of evaluation of this end point: Weeks 13 and 25 Treatment phases weeks 1-13 and 13-25	—

Measure

Time frame

Secondary end point(s): Secondary endpoints are to compare the following parameters with or without allopurinol treatment: -tThe mean level of 6TG and DNA-TGN at week 13 and 25 -The mean level of 6MMP at week 13 and 25 -The weighted mean level of Hb, WBC, platelets and ANC during the respective treatment phases -Laboratory measures of hepatotoxicity (weighed mean S-Bilirubin and S-GPT) during treatment phases -Laboratory measures of hypoglycaemia and metabolic dysfunction (cumulative incidence of hypoglycaemia during the treatment phases) -Serious adverse events (cumulative incidence during the treatment phases) -The mean cumulative doses of 6MP and Mix days with treatment interruption during the two treatment phases;Timepoint(s) of evaluation of this end point: Weeks 13 and 25 Treatment phases weeks 1-13 and 13-25

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Countries

Finland, Sweden

Contacts

Public ContactJonas Abrahamsson

Queen Silvias Childrens and Adolescents Hospital

vobjab@gmail.com+4631215486

Outcome results

None listed

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