Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy

NCT ID: NCT03920813

Last Updated: 2019-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antitumor drugs

Mercaptopurine administered at standard dose for children with hematological neoplasms.

Group Type EXPERIMENTAL

Mercaptopurine

Intervention Type DRUG

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

Interventions

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Mercaptopurine

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

Intervention Type DRUG

Other Intervention Names

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Purinethol

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Wei Zhao

Head of department of clinical pharmacy and pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Zhao, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shandong University

Other Identifiers

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2018Mercaptopurine001

Identifier Type: -

Identifier Source: org_study_id

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