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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03022747
• Date of registration: 09/01/2017
• Prospective Registration: No
• Primary sponsor: Vastra Gotaland Region
• Public title: Optimizing 6-mercaptopurine Therapy in Pediatric Acute Lymphoblastic Leukemia by Using Allopurinol
• Scientific title: 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.
• Date of first enrolment: January 2017
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03022747
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Finland, Sweden

Contacts

• Name: Jonas Abrahamsson, PhD, MD
• Affiliation: Childrens Cancer Center, Queen Silvia Children Hospital, Sahlgrenska Academy, Gothenburg, Sweden

• Name: Riita Niinimäki, PhD, MD
• Affiliation: Dept of Pediatrics and Adolescents, Oulu University Hospital, Box 23, 90029 OYS, Finland

• Name: Jonas Abrahamsson, PhD, MD

Key inclusion & exclusion criteria

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.



Age minimum: 6 Months
Age maximum: 19 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lymphoblastic Leukemia, Acute, Childhood

Intervention(s)

Drug: Standard treatment

Drug: Allopurinol

Primary Outcome(s)

6-thioguanine (6TG) levels in erythrocytes [Time Frame: Up to week 25]

Secondary Outcome(s)

Mean level of 6-methylmercaptopurine (6MMP) [Time Frame: Up to week 25]

Hypoglycemia [Time Frame: Up to week 25]

Mean levels of platelets [Time Frame: Up to week 25]

Mean level of DNA-incorporated thioguanine (DNA-TGN) [Time Frame: Up to week 25]

Incidence of serious adverse events (SAE) [Time Frame: Up to week 29]

Mean level of 6-thioguanine [Time Frame: Up to week 25]

Metabolic disturbance [Time Frame: Up to week 25]

Bilirubin [Time Frame: Up to week 25]

Mean levels of white blood cells (WBC) [Time Frame: Up to week 25]

Mean levels of hemoglobin [Time Frame: Up to week 25]

Cumulative dose of 6-mercaptopurine and methotrexate [Time Frame: Up to week 29]

Glutamate pyruvate transaminase (GPT) [Time Frame: Up to week 25]

Mean levels of absolute neutrophil count (ANC) [Time Frame: Up to week 25]

Secondary ID(s)

Allopurinol Study V3.0

Source(s) of Monetary Support

Please refer to primary and secondary sponsors