Pediatric CancerPhase 4CHAPATINCT05844670
CHildren Treated With Vincristine: A Trial Regarding Pharmacokinetics, DNA And Toxicity of Targeted Therapy In Pediatric Oncology Patients.
A Phase 4 study testing Vincristine in people with Pediatric Cancer, run by Moi University at 1 site in Kenya.
Trial summary
The goal of this clinical trial is to individualize the dosage of vincristine, a chemotherapy drug, in children with cancer. The main question it aims to answer is: can vincristine dosage be optimized while carefully monitoring toxicity. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Vincristine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteKenya
- Study dates
- 20 Apr 2023to 1 Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Black patients aged 5-14 years with a malignancy for which they are scheduled to receive a minimum of two VCR administrations as part of their treatment protocol: acute lymphoblastic leukemia, non-Hodgkin's lymphoma, rhabdomyosarcoma, neuroblastoma, nephroblastoma, retinoblastoma.
- Written informed consent
- Black patients aged 2-14 years with a malignancy for which they are scheduled to receive a minimum of four VCR administrations as part of their treatment protocol: acute lymphoblastic leukemia, non-Hodgkin's lymphoma, rhabdomyosarcoma, neuroblastoma, nephroblastoma, retinoblastoma.
- Written informed consent
Who cannot join
- Severe malnutrition
- Total bilirubin >3 times upper limit of normal
- Pre-existent severe mental retardation e.g. Down syndrome
- Pre-existent peripheral neuropathy (CTCAE constipation, peripheral sensory neuropathy, peripheral motor neuropathy, or neuralgia ≥ 2 or ped-mTNS ≥ 5)
- Rest of the study:
- Severe malnutrition
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- Total bilirubin >3 times upper limit of normal
- Pre-existent severe mental retardation e.g. Down syndrome
- Pre-existent peripheral neuropathy (CTCAE constipation, peripheral sensory neuropathy, peripheral motor neuropathy, or neuralgia ≥ 2 or ped-mTNS ≥ 5)
Trial locations and contacts
1 site in 1 country.
Kenya1 site, 1 recruiting
- Recruiting
Moi Teaching and Referral Hospital
Eldoret, Rift Valley, P.o. Box 3-30100
Aniek Uittenboogaard, MD, +31631293157, a.uittenboogaard@amsterdamumc.nl
Festus M Njuguna, MD, PhD, +254532032393, muigaifes2000@yahoo.com
About this study
The goal of this clinical trial is to individualize the dosage of vincristine, a chemotherapy drug, in children with cancer. The main question it aims to answer is: can vincristine dosage be optimized while carefully monitoring toxicity.
The following will happen:
- Participants will receive vincristine according to the institutional treatment protocol.
- After receiving vincristine, blood samples will be taken at three time points.
- The amount of vincristine in the blood samples will be determined.
- If the amount of vincristine in the blood samples is lower than the reference and the participants do not experience toxicity due to vincristine, the dose of vincristine may be increased.
- Toxicity will be carefully monitored.
Read the detailed description
Vincristine is among the most widely used and potentially effective chemotherapeutic agents in pediatric oncology patients. However, in black African children it may be sub optimally dosed due to genetic differences in the metabolism of vincristine. This study aims to optimize the dosing regimen of vincristine while carefully monitoring toxicity.
This will be a prospective cohort study consisting of two parts: a feasibility study and the rest of the study. In the feasibility study, 15 children aged 5-14 years who are scheduled to receive at least 2 vincristine administrations can be included. After the administration of vincristine, venous blood samples and finger prick blood samples will be taken to determine the vincristine concentrations. The samples will be shipped to and analyzed in the Netherlands to determine the vincristine concentration in each sample. Based on this, a dose advise will be given for subsequent vincristine administrations. This cycle will be repeated maximum 2 times but maximum 1 dose advice is given. Toxicity will be monitored by determination of the bilirubin, by questionnaires and by physical examination to check for signs of peripheral neuropathy. In the rest of the study, in which 85 children will be included, only finger prick samples will be taken.
- Conditions
- Pediatric Cancer
- Being tested
- Vincristine
- Keywords
- Pharmacokinetics, Vincristine-induced peripheral neuropathy, Pediatric oncology, Vincristine, Individualized dosing
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VincristineDrug
The initial vincristine dosage will be according to institutional treatment protocol. After vincristine administration, three blood samples will be taken at T=1, T=1.5 and T=4 hours. The concentration of vincristine will be analyzed in the samples. If the concentration of 2 or more samples is lower than the reference concentration and there is no toxicity, an advice will be given to increase dosage by 20%. Whether or not a dosage is given, vincristine concentrations will be measured again for the next dose administration.
For the feasibility study, both venous blood samples and finger prick blood samples using Mitra tips will be taken. The cycle can be repeated maximum 2 times.
For the rest of the study, finger prick blood samples using Mitra tips will be taken. The cycle can be repeated maximum 3 times.
Toxicity will be monitored through physical exam and questionnaire, bilirubin levels and clinical status of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Vincristine | Experimental | A dose advice for vincristine will be given based on vincristine concentrations in blood samples and toxicity monitoring. Receives: Drug: Vincristine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adapting vincristine dosage
The number of patients in whom it is possible to adapt vincristine dosage based on vincristine concentrations in the blood at three time points and the presence of side-effects.
Measured: Through study completion, an average of four months per patient (depending on treatment protocol).
Secondary outcomes (3)
Vincristine-induced peripheral neuropathy
The number of patients who develop vincristine-induced peripheral neuropathy (VIPN) and the degree of VIPN. VIPN is measured using the CTCAE v5 items peripheral sensory neuropathy, peripheral motor neuropathy, neuralgia and constipation. In children aged 5 or above, VIPN will also be assessed with the ped-mTNS.
Measured: Through study completion, an average of four months per patient (depending on treatment protocol).
Genetics
The association between pharmacogenomic parameters and the concentration of vincristine at three time points (T=60 minutes, T=90 minutes and T=240 minutes after vincristine administration) and vincristine-induced peripheral neuropathy using CTCAE v5 and ped-mTNS.
Measured: Through study completion, an average of four months per patient (depending on treatment protocol).
Vincristine pharmacokinetics
The median vincristine concentrations and interquartile ranges (IQR) on three time points (T=60 minutes, T=90 minutes and T=240 minutes after vincristine administration).
Measured: Through study completion, an average of four months per patient (depending on treatment protocol).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start20 Apr 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies 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
- Model description
- This will be a prospective cohort study.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moi University
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Maxima Center for Pediatric Oncology, Amsterdam UMC, location VUmc
- Responsible party
- Sponsor
- Investigators
- Festus M Njuguna, MD, PhD, Principal investigator, Moi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844670
- Sponsor's protocol ID
- V314092022
- Acronym
- CHAPATI
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data are available upon reasonable request.
Publications
Uittenboogaard A, van de Velde M, van de Heijden L, Mukuhi L, de Vries N, Langat S, Olbara G, Huitema ADR, Vik T, Kaspers G, Njuguna F. Vincristine exposure in Kenyan children with cancer: CHAPATI feasibility study. Pediatr Blood Cancer. 2024 Sep;71(9):e31160. doi: 10.1002/pbc.31160. Epub 2024 Jul 2.
PubMed 38956809
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHildren Treated With Vincristine: A Trial Regarding Pharmacokinetics, DNA And Toxicity of Targeted Therapy In Pediatric Oncology Patients.
- ClinicalTrials.gov ID
- NCT05844670
- Acronym / sponsor ID
- CHAPATI / V314092022
- Conditions
- Pediatric Cancer
- Keywords
- Pharmacokinetics, Vincristine-induced peripheral neuropathy, Pediatric oncology, Vincristine, Individualized dosing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Moi UniversityUniversity, hospital or other
- Collaborators
- Princess Maxima Center for Pediatric Oncology, Amsterdam UMC, location VUmc
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 6 May 2023 (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 goal of this clinical trial is to individualize the dosage of vincristine, a chemotherapy drug, in children with cancer. The main question it aims to answer is: can vincristine dosage be optimized while carefully monitoring toxicity.
The following will happen:
- Participants will receive vincristine according to the institutional treatment protocol.
- After receiving vincristine, blood samples will be taken at three time points.
- The amount of vincristine in the blood samples will be determined.
- If the amount of vincristine in the blood samples is lower than the reference and the participants do not experience toxicity due to vincristine, the dose of vincristine may be increased.
- Toxicity will be carefully monitored.
Detailed description
Vincristine is among the most widely used and potentially effective chemotherapeutic agents in pediatric oncology patients. However, in black African children it may be sub optimally dosed due to genetic differences in the metabolism of vincristine. This study aims to optimize the dosing regimen of vincristine while carefully monitoring toxicity.
This will be a prospective cohort study consisting of two parts: a feasibility study and the rest of the study. In the feasibility study, 15 children aged 5-14 years who are scheduled to receive at least 2 vincristine administrations can be included. After the administration of vincristine, venous blood samples and finger prick blood samples will be taken to determine the vincristine concentrations. The samples will be shipped to and analyzed in the Netherlands to determine the vincristine concentration in each sample. Based on this, a dose advise will be given for subsequent vincristine administrations. This cycle will be repeated maximum 2 times but maximum 1 dose advice is given. Toxicity will be monitored by determination of the bilirubin, by questionnaires and by physical examination to check for signs of peripheral neuropathy. In the rest of the study, in which 85 children will be included, only finger prick samples will be taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a prospective cohort study.
| Arm | Type | Receives |
|---|---|---|
| Vincristine | Experimental | Drug: VincristineA dose advice for vincristine will be given based on vincristine concentrations in blood samples and toxicity monitoring. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Black patients aged 5-14 years with a malignancy for which they are scheduled to receive a minimum of two VCR administrations as part of their treatment protocol: acute lymphoblastic leukemia, non-Hodgkin's lymphoma, rhabdomyosarcoma, neuroblastoma, nephroblastoma, retinoblastoma.
- Written informed consent
- Black patients aged 2-14 years with a malignancy for which they are scheduled to receive a minimum of four VCR administrations as part of their treatment protocol: acute lymphoblastic leukemia, non-Hodgkin's lymphoma, rhabdomyosarcoma, neuroblastoma, nephroblastoma, retinoblastoma.
- Written informed consent
Key exclusion criteria (9 listed)
- Severe malnutrition
- Total bilirubin >3 times upper limit of normal
- Pre-existent severe mental retardation e.g. Down syndrome
- Pre-existent peripheral neuropathy (CTCAE constipation, peripheral sensory neuropathy, peripheral motor neuropathy, or neuralgia ≥ 2 or ped-mTNS ≥ 5)
- Severe malnutrition
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 |
|---|---|---|
| VincristineThe initial vincristine dosage will be according to institutional treatment protocol. After vincristine administration, three blood samples will be taken at T=1, T=1.5 and T=4 hours. The concentration of vincristine will be analyzed in the samples. If the concentration of 2 or more samples is lower than the reference concentration and there is no toxicity, an advice will be given to increase dosage by 20%. Whether or not a dosage is given, vincristine concentrations will be measured again for the next dose administration. For the feasibility study, both venous blood samples and finger prick blood samples using Mitra tips will be taken. The cycle can be repeated maximum 2 times. For the rest of the study, finger prick blood samples using Mitra tips will be taken. The cycle can be repeated maximum 3 times. Toxicity will be monitored through physical exam and questionnaire, bilirubin levels and clinical status of the patient. | Drug | Vincristine |
Primary outcome
Adapting vincristine dosage
Time frame: Through study completion, an average of four months per patient (depending on treatment protocol).
The number of patients in whom it is possible to adapt vincristine dosage based on vincristine concentrations in the blood at three time points and the presence of side-effects.
3 secondary outcomes
Vincristine-induced peripheral neuropathy
Time frame: Through study completion, an average of four months per patient (depending on treatment protocol).
Genetics
Time frame: Through study completion, an average of four months per patient (depending on treatment protocol).
Vincristine pharmacokinetics
Time frame: Through study completion, an average of four months per patient (depending on treatment protocol).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 38956809Uittenboogaard A, van de Velde M, van de Heijden L, Mukuhi L, de Vries N, Langat S, Olbara G, Huitema ADR, Vik T, Kaspers G, Njuguna F. Vincristine exposure in Kenyan children with cancer: CHAPATI feasibility study. Pediatr Blood Cancer. 2024 Sep;71(9):e31160. doi: 10.1002/pbc.31160. Epub 2024 Jul 2.
- Individual participant dataSharing planned: Yes. The data are available upon reasonable request.
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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. This study is not recruiting at the moment.
Festus M Njuguna, MD, PhD principal investigator
Moi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vincristine in people with Pediatric Cancer, run by Moi University at 1 site in Kenya.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aniek Uittenboogaard, MD (+31631293157, a.uittenboogaard@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adapting vincristine dosage (time frame: Through study completion, an average of four months per patient (depending on treatment protocol).). 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 NCT05844670, which also lists 1 linked publication.
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 6 May 2023.