Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy

• Status: Enrolling by invitation
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The present study was conducted to assess the population pharmacokinetics of 6-mercaptopurine (6-MP) in Pediatric Acute Lymphoblastic Leukemia (ALL) and genetic polymorphisms

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong University
• Treatments: Mercaptopurine

Criteria

Inclusion Criteria:

• Patients have been diagnosed with Acute Lymphoblastic Leukemia

• Childhood patients who were undergoing chemotherapy or continuous follow-up after completion of chemotherapy

• Patients received the phase of maintenance therapy that included oral 6-MP (>4 weeks) and completion of ≥ 6 months according to the CCLG (Chinese Children's Leukemia Group) protocol-ALL 2015

Exclusion Criteria:

• Patients with high-risk ALL (presence of higher-risk features: MRD ≥ 1% at 46 day, or age < 6 month and white blood cell (WBC) count ≥ 300×109/L with translocations t(9;22) (q34;q11) [BCR-ABL], t(4;11) (q21;q23) [AF4/MLL], t(1;19) (q23;p13) [E2A-PBX1] or other MLL-rearrangements) were removed