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NCT03920813 Clinical Trial

Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy

Acute Lymphoblastic Leukemia Clinical Trial

Official title:
Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03920813
Other study ID # 2018Mercaptopurine001
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date January 2015
Est. completion date December 2021

Study information
Verified date April 2019
Source Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 500
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shandong University

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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