Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy

Phase 4

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Drug: Mercaptopurine

• Registration Number: NCT03920813
• Lead Sponsor: Shandong University

Brief 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

Detailed Description

The investigators' purpose was to identify genetic factors and metabolite concentrations associated with both hematological toxicity in patients with ALL maintained on 6-MP in Chinese.

Study Timeline

• Study Start: 2015-01
• Status Verified: 2019-04
• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-19
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-23
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antitumor drugs	Mercaptopurine	Mercaptopurine administered at standard dose for children with hematological neoplasms.

Primary Outcome Measures

Name	Time	Method
Red blood cells (RBC) concentration of 6-mercaptopurine (6-MP)	at second day after oral administration	To detect of RBC 6-MP metabolite concentrations and evaluate the association of metabolite concentrations and side effects
Genetic polymorphisms in Chinese patients with ALL	at second day after oral administration	To detect the frequencies of genetic polymorphisms of Chinese patients receiving 6-MP for treatment of ALL