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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy

Clinicaltrials.gov identifier NCT03920813

Recruitment Status Enrolling by invitation

First Posted April 19, 2019

Last update posted April 23, 2019

Study Description

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

  • Condition or Disease:Acute Lymphoblastic Leukemia
  • Intervention/Treatment: Drug: Mercaptopurine
  • Phase: Phase 4
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 500 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic
  • Actual Study Start Date: January 2015
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Antitumor drugs
Mercaptopurine administered at standard dose for children with hematological neoplasms.
Drug: Mercaptopurine
Dose of mercaptopurine was adjusted to maintain a target white blood cells (WBC) between 2.0-3.0 × 109/L.
Outcome Measures
  • Primary Outcome Measures: 1. Red blood cells (RBC) concentration of 6-mercaptopurine (6-MP) [ Time Frame: at second day after oral administration ]
    To detect of RBC 6-MP metabolite concentrations and evaluate the association of metabolite concentrations and side effects
  • 2. Genetic polymorphisms in Chinese patients with ALL [ Time Frame: at second day after oral administration ]
    To detect the frequencies of genetic polymorphisms of Chinese patients receiving 6-MP for treatment of ALL
Eligibility Criteria
  • Ages Eligible for Study: 1 to 18 Year (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations
Sponsors and Collaborators

Shandong University


Principal Investigator: Wei Zhao, Ph.D Shandong University

More Information
  • Responsible Party: Shandong University
  • ClinicalTrials.gov Identifier: NCT03920813 History of Changes
  • Other Study ID Numbers: 2018Mercaptopurine001
  • First Posted: April 19, 2019 Key Record Dates
  • Last Update Posted: April 23, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Leukemia, Lymphoid
    Precursor Cell Lymphoblastic Leukemia-Lymphoma