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Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy

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ClinicalTrials.gov Identifier: NCT03920813
Recruitment Status : Enrolling by invitation
First Posted : April 19, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Wei Zhao, Shandong University

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
Acute Lymphoblastic Leukemia Drug: Mercaptopurine 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.

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Study Type : Interventional  (Clinical Trial)
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


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 Name: Purinethol




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



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920813


Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Wei Zhao, Ph.D Shandong University

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Responsible Party: Wei Zhao, Head of department of clinical pharmacy and pharmacology, 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

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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:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Mercaptopurine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors