Back to resultsDeterminants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy
Primary Purpose
Acute Lymphoblastic Leukemia
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Mercaptopurine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Antitumor drugs
Arm Description
Mercaptopurine administered at standard dose for children with hematological neoplasms.
Outcomes
Primary Outcome Measures
Red blood cells (RBC) concentration of 6-mercaptopurine (6-MP)
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
To detect the frequencies of genetic polymorphisms of Chinese patients receiving 6-MP for treatment of ALL
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03920813
Brief Title
Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy
Official Title
Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antitumor drugs
Arm Type
Experimental
Arm Description
Mercaptopurine administered at standard dose for children with hematological neoplasms.
Intervention Type
Drug
Intervention Name(s)
Mercaptopurine
Other Intervention Name(s)
Purinethol
Intervention Description
Dose of mercaptopurine was adjusted to maintain a target white blood cells (WBC) between 2.0-3.0 × 109/L.
Primary Outcome Measure Information:
Title
Red blood cells (RBC) concentration of 6-mercaptopurine (6-MP)
Description
To detect of RBC 6-MP metabolite concentrations and evaluate the association of metabolite concentrations and side effects
Time Frame
at second day after oral administration
Title
Genetic polymorphisms in Chinese patients with ALL
Description
To detect the frequencies of genetic polymorphisms of Chinese patients receiving 6-MP for treatment of ALL
Time Frame
at second day after oral administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhao, Ph.D
Organizational Affiliation
Shandong University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy
We'll reach out to this number within 24 hrs