Clincosm LogoSign in Get a demo

Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy

Sponsor
Shandong University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03920813
Collaborator
(none)
500
Enrollment
1
Arm
83
Anticipated Duration (Months)

Study Details

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 Intervention/Treatment 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
Anticipated Enrollment :
500 participants
Allocation:
N/A
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 :
Jan 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 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.
Other Names:
  • Purinethol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shandong University

    Investigators

    • Principal Investigator: Wei Zhao, Ph.D, Shandong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wei Zhao, Head of department of clinical pharmacy and pharmacology, Shandong University
    ClinicalTrials.gov Identifier:
    NCT03920813
    Other Study ID Numbers:
    • 2018Mercaptopurine001
    First Posted:
    Apr 19, 2019
    Last Update Posted:
    Apr 23, 2019
    Last Verified:
    Apr 1, 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.:
    No
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid
    Mercaptopurine

    Study Results

    No Results Posted as of Apr 23, 2019