Hematological NeoplasmsPhase 4NCT03844360
Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease
A Phase 4 study testing Bortezomib, Eltrombopag and Imatinib in people with Hematological Neoplasms, run by Wei Zhao at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Hematological Neoplasms
- What is being tested?
- Bortezomib, Eltrombopag and Imatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 2 sitesChina
- Study dates
- 31 Jan 2016to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must be diagnosed with hematological neoplasms
- Antineoplastic drugs or anti-infective drugs used as part of regular treatment
Who cannot join
- expected survival time less than the treatment cycle;
- patients with other factors that researcher considers unsuitable for inclusion.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 1 recruiting
- Recruiting
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
Tanjin, Tianjin Municipality, 300020
- Completed
Department of Pediatrics, the Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
About this study
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.
Read the 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.
- Conditions
- Hematological Neoplasms
- Being tested
- Bortezomib, Eltrombopag, Imatinib, dasatinib, Pegaspargase
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called Velcade
bortezomib was administered follow the doctor's advice.
EltrombopagDrug
Also called promacta
eltrombopag was administered follow the doctor's advice.
ImatinibDrug
Also called Gleevec
imatinib was administered follow the doctor's advice.
dasatinibDrug
Also called sprycel
dasatinib was administered follow the doctor's advice.
PegaspargaseDrug
Also called Oncaspar
pegaspargase was administered follow the doctor's advice.
Anti-Infective DrugsDrug
anti-infective drugs was administered follow the doctor's advice.
PEGylated Recombinant Human Granulocyte Colony-Stimulating FactorDrug
Also called PEG-rhG-CSF
pegaspargase was administered follow the doctor's advice.
| Study group | Role | What they receive |
|---|---|---|
| Antineoplastic Drugs and Anti-infective Drugs | Experimental | Bortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms. Receives: Drug: Bortezomib; Drug: Eltrombopag; Drug: Imatinib; Drug: dasatinib; Drug: Pegaspargase; Drug: Anti-Infective Drugs; Drug: PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of plasma concentration of bortezomib
To detect the plasma concentrations of bortezomib after administration
Measured: at(0-0.5)h,(0.5-3)h,(24-48)h,(48-72)h hours after administration
change of plasma concentration of eltrombopag
To detect the plasma concentrations of eltrombopag after administration
Measured: at (0.5-3)h,(3-6)h,(10-14)h,(20-24)h hours after oral administration
change of plasma concentration of imatinib
To detect the plasma concentrations of imatinib after administration
Measured: at (0.5-2)h,(2-4)h,(10-14)h,(20-24)h hours after oral administration
change of plasma concentration of dasatinib
To detect the plasma concentrations of dasatinib after administration
Measured: at(0-0.5)h,(0.5-3)h,(10-14)h,(20-24)h hours after oral administration
change of plasma concentration of pegaspargase
To detect the plasma concentrations of pegaspargase after administration
Measured: at Day-1,Day(0-1),Day(3-5),Day(8-10),Day(13-14) after administration
plasma concentration of anti-infective drug
To detect the plasma concentrations of anti-infective drug after administration
Measured: through study completion, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start31 Jan 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hematological NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Zhao, Shandong University
- Investigators
- Wei Zhao, Ph.D, Principal investigator, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844360
- Sponsor's protocol ID
- Antineoplastic Drugs001
- Status last verified
- Apr 2019
- First submitted
- 12 Feb 2019
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang W, Chang LX, Zhao BB, Zheng Y, Shan DD, Tang BH, Yang F, Zhou Y, Hao GX, Zhang YH, van den Anker J, Zhu XF, Zhang L, Zhao W. Efficacy, Safety, and Population Pharmacokinetics of Eltrombopag in Children with Different Severities of Aplastic Anemia. J Clin Pharmacol. 2024 Aug;64(8):932-943. doi: 10.1002/jcph.2430. Epub 2024 Mar 18.
PubMed 38497347Yang F, Zhang L, Zhao BB, Zhang JL, Liu XT, Li X, Tang BH, Zhou Y, Yang XM, van den Anker J, Zhu XF, Zhao W. Population Pharmacokinetics and Safety of Dasatinib in Chinese Children with Core-Binding Factor Acute Myeloid Leukemia. Clin Pharmacokinet. 2022 Jan;61(1):71-81. doi: 10.1007/s40262-021-01054-6. Epub 2021 Jul 9.
PubMed 34240339
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease
- ClinicalTrials.gov ID
- NCT03844360
- Acronym / sponsor ID
- Antineoplastic Drugs001
- Conditions
- Hematological Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Wei ZhaoUniversity, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 31 Jan 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antineoplastic Drugs and Anti-infective Drugs | Experimental | Drug: Bortezomib, Drug: Eltrombopag, Drug: Imatinib, Drug: dasatinib, Drug: Pegaspargase, Drug: Anti-Infective Drugs, Drug: PEGylated Recombinant Human Granulocyte Colony-Stimulating FactorBortezomib;eltrombopag;imatinib;dasatinib, pegaspargase and anti-infective drugs administered at standard dose for children with hematological neoplasms. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients must be diagnosed with hematological neoplasms
- Antineoplastic drugs or anti-infective drugs used as part of regular treatment
Key exclusion criteria (2 listed)
- expected survival time less than the treatment cycle;
- patients with other factors that researcher considers unsuitable for inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BortezomibAlso: Velcadebortezomib was administered follow the doctor's advice. | Drug | Antineoplastic Drugs and Anti-infective Drugs |
| EltrombopagAlso: promactaeltrombopag was administered follow the doctor's advice. | Drug | Antineoplastic Drugs and Anti-infective Drugs |
| ImatinibAlso: Gleevecimatinib was administered follow the doctor's advice. | Drug | Antineoplastic Drugs and Anti-infective Drugs |
| dasatinibAlso: spryceldasatinib was administered follow the doctor's advice. | Drug | Antineoplastic Drugs and Anti-infective Drugs |
| PegaspargaseAlso: Oncasparpegaspargase was administered follow the doctor's advice. | Drug | Antineoplastic Drugs and Anti-infective Drugs |
| Anti-Infective Drugsanti-infective drugs was administered follow the doctor's advice. | Drug | Antineoplastic Drugs and Anti-infective Drugs |
| PEGylated Recombinant Human Granulocyte Colony-Stimulating FactorAlso: PEG-rhG-CSFpegaspargase was administered follow the doctor's advice. | Drug | Antineoplastic Drugs and Anti-infective Drugs |
Primary outcome
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 38497347Zhang W, Chang LX, Zhao BB, Zheng Y, Shan DD, Tang BH, Yang F, Zhou Y, Hao GX, Zhang YH, van den Anker J, Zhu XF, Zhang L, Zhao W. Efficacy, Safety, and Population Pharmacokinetics of Eltrombopag in Children with Different Severities of Aplastic Anemia. J Clin Pharmacol. 2024 Aug;64(8):932-943. doi: 10.1002/jcph.2430. Epub 2024 Mar 18.
- Derived from this study: PubMed 34240339Yang F, Zhang L, Zhao BB, Zhang JL, Liu XT, Li X, Tang BH, Zhou Y, Yang XM, van den Anker J, Zhu XF, Zhao W. Population Pharmacokinetics and Safety of Dasatinib in Chinese Children with Core-Binding Factor Acute Myeloid Leukemia. Clin Pharmacokinet. 2022 Jan;61(1):71-81. doi: 10.1007/s40262-021-01054-6. Epub 2021 Jul 9.
Related trials for Hematological Neoplasms
Not yet recruitingPhase 4
MACE and BTK Inhibitors
Hematologic Cancer, MACE
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Zhao, Ph.D principal investigator
Shandong University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bortezomib, Eltrombopag and Imatinib in people with Hematological Neoplasms, run by Wei Zhao at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhao, Ph.D (86053188383308, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03844360, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.