Clinical trial · Interventional
Optimizing 6-mercaptopurine Therapy in Pediatric Acute Lymphoblastic Leukemia by Using Allopurinol
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoblastic Leukemia, Acute, Childhood | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allopurinol | Drug | — | UNRESOLVED |
| Standard treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard maintenance therapy
- description
- Standard maintenance therapy with 6 mercaptopurine and methotrexate
- interventionNames
- Drug: Standard treatment
- type
- EXPERIMENTAL
- label
- Allopurinol treatment
- description
- The second 12 week phase during which allopurinol is added to oral 6-mercaptopurine and methotrexate therapy
- interventionNames
- Drug: Allopurinol
Primary outcomes (1)
- measure
- 6-thioguanine (6TG) levels in erythrocytes
- timeFrame
- Up to week 25
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of acute lymphoblastic leukemia * Treatment according to Nordic Society for pediatric hematology/oncology (NOPHO) ALL2008 based protocols * Age 0-18y at time of initial diagnosis * TPMT wild type * Written informed consent 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 * Severe liver toxicity defined as persistent (≥ two weeks) elevation of either S-bilirubin \> 50 μmol/l or S-GPT \> 20 x Upper normal limit (UNL) or P-Prothrombin complex \> 1.5. * Reduced kidney function defined as S-creatinine ≥ 1.5 x UNL. * Lactating female or female of childbearing potential not using adequate contraception.
References
Publications (0)
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