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Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease

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ClinicalTrials.gov Identifier: NCT03844360
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Wei Zhao, Shandong University

Study Description
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Brief Summary:
The investigators' purpose was to assess the feasibility of dosage individualization of the commonly used antineoplastic drugs and anti-infective drugs in children with hematoplastic disease.

Condition or disease Intervention/treatment Phase
Hematological Neoplasms Drug: Bortezomib Drug: Eltrombopag Drug: Imatinib Drug: dasatinib Drug: Pegaspargase Drug: Anti-Infective Drugs Phase 4

Detailed Description:
The investigators' purpose was to assess the feasibility of dosage individualization of the commonly used antineoplastic drugs and anti-infective drugs based on the opportunistic sampling strategy in children with confirmed or suspected hematological neoplasms.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease
Actual Study Start Date : January 31, 2016
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Antineoplastic Drugs and Anti-infective Drugs
Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms.
 Drug: Bortezomib
bortezomib was administered follow the doctor's advice.
Other Name: Velcade

Drug: Eltrombopag
eltrombopag was administered follow the doctor's advice.
Other Name: promacta

Drug: Imatinib
imatinib was administered follow the doctor's advice.
Other Name: Gleevec

Drug: dasatinib
dasatinib was administered follow the doctor's advice.
Other Name: sprycel

Drug: Pegaspargase
pegaspargase was administered follow the doctor's advice.
Other Name: Oncaspar

Drug: Anti-Infective Drugs
anti-infective drugs was administered follow the doctor's advice.


Outcome Measures
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Primary Outcome Measures :
  1. change of plasma concentration of bortezomib [ Time Frame: at(0-0.5)h,(0.5-3)h,(24-48)h,(48-72)h hours after administration ]
    To detect the plasma concentrations of bortezomib after administration

  2. change of plasma concentration of eltrombopag [ Time Frame: at (0.5-3)h,(3-6)h,(10-14)h,(20-24)h hours after oral administration ]
    To detect the plasma concentrations of eltrombopag after administration

  3. change of plasma concentration of imatinib [ Time Frame: at (0.5-2)h,(2-4)h,(10-14)h,(20-24)h hours after oral administration ]
    To detect the plasma concentrations of imatinib after administration

  4. change of plasma concentration of dasatinib [ Time Frame: at(0-0.5)h,(0.5-3)h,(10-14)h,(20-24)h hours after oral administration ]
    To detect the plasma concentrations of dasatinib after administration

  5. change of plasma concentration of pegaspargase [ Time Frame: at Day-1,Day(0-1),Day(3-5),Day(8-10),Day(13-14) after administration ]
    To detect the plasma concentrations of pegaspargase after administration

  6. plasma concentration of anti-infective drug [ Time Frame: through study completion, an average of 14 days ]
    To detect the plasma concentrations of anti-infective drug after administration


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

Inclusion Criteria:

  • Patients must be diagnosed with hematological neoplasms
  • Antineoplastic drugs or anti-infective drugs used as part of regular treatment

Exclusion Criteria:

  • expected survival time less than the treatment cycle;
  • patients with other factors that researcher considers unsuitable for inclusion.
Contacts and Locations
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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): NCT03844360


Contacts
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Contact: Wei Zhao, Ph.D 86053188383308 zhao4wei2@hotmail.com
Contact: Yan H Shi, Ph.D 86053188383308 zhao4wei2@hotmail.com

Locations
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China, Tianjin
State Key Laboratory of Experimental Haematology, Department of Paediatric Haematology, Institute of Haematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Recruiting
Tanjin, Tianjin, China, 300020
Sponsors and Collaborators
Wei Zhao
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Wei Zhao, Ph.D Shandong University
More Information
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Responsible Party: Wei Zhao, Professor; Head of department of clinical pharmacy and pharmacology, Shandong University
ClinicalTrials.gov Identifier: NCT03844360     History of Changes
Other Study ID Numbers: Antineoplastic Drugs001
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: April 30, 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
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases
Bortezomib
Imatinib Mesylate
Dasatinib
 Pegaspargase
Antineoplastic Agents
Anti-Infective Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action