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出境医 / 临床实验 / Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy

Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy

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
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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : 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.
Other Name: Purinethol
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
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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
Contacts and Locations

Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Wei Zhao, Ph.D Shandong University
Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date April 23, 2019
Actual Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • change of red blood cells concentration of 6-mercaptopurine (6-MP) [ Time Frame: at second day after oral administration ]
    To detect the red blood cells concentrations of 6-MP after administration
  • Genetic polymorphisms in Chinese patients with ALL [ Time Frame: at second day after oral administration ]
    To detect genetic polymorphisms of Chinese patients receiving 6-MP for treatment of ALL
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy
Official Title  ICMJE Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Lymphoblastic Leukemia
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Antitumor drugs
Mercaptopurine administered at standard dose for children with hematological neoplasms.
Intervention: Drug: Mercaptopurine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: April 17, 2019) 		500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03920813
Other Study ID Numbers  ICMJE 2018Mercaptopurine001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wei Zhao, Shandong University
Study Sponsor  ICMJE Shandong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wei Zhao, Ph.D Shandong University
PRS Account Shandong University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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