Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy

NCT03920813 | Unknown Phase 4 DMC

• 1 other identifier: 2018Mercaptopurine001
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• Red blood cells (RBC) concentration of 6-mercaptopurine (6-MP)

  To detect of RBC 6-MP metabolite concentrations and evaluate the association of metabolite concentrations and side effects

  at second day after oral administration

• Genetic polymorphisms in Chinese patients with ALL

  To detect the frequencies of genetic polymorphisms of Chinese patients receiving 6-MP for treatment of ALL

  at second day after oral administration

Study Arms (1)

Antitumor drugs

EXPERIMENTAL

Mercaptopurine administered at standard dose for children with hematological neoplasms.

Drug: Mercaptopurine

Interventions

Mercaptopurine DRUG

Dose of mercaptopurine was adjusted to maintain a target white blood cells (WBC) between 2.0-3.0 × 109/L.

Also known as: Purinethol

Antitumor drugs

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Mercaptopurine

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Wei Zhao, Ph.D

  Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of clinical pharmacy and pharmacology

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 19, 2019
• Study Start: January 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 23, 2019

Record last verified: 2019-04