Methotrexate Adverse ReactionHDMTXNCT02011022
Pharmacokinetic Analysis of High Dose Methotrexate in Pediatric Lymphoblastic Malignancies
A study testing 3g MTX and 5g MTX in people with Methotrexate Adverse Reaction, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
The pharmacokinetics of MTX were assessed with regards to the relevance of several different patient specific factors in 291 pediatric patients, who were administered with high dose of MTX. Population pharmacokinetics of MTX analysis was performed by using nonlinear mixed effects modeling. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Methotrexate Adverse Reaction
- What is being tested?
- 3g MTX and 5g MTX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 1 siteChina
- Study dates
- May 2009to Feb 2010
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Acute lymphoblastic leukemia and non-hodgkin's lymphoma younger than 18 years old
Who cannot join
- Non lymphoblastic malignancies or older than 18 years
Trial locations and contacts
1 site in 1 country.
China1 site
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
About this study
Official title: Pharmacokinetic Analysis of High Dose Methotrexate in Pediatric Acute Lymphoblastic Leukemia: Significant Impact Factors and Establishment of a Clinically Relevant Model
- The pharmacokinetics of MTX were assessed with regards to the relevance of several different patient specific factors in 291 pediatric patients, who were administered with high dose of MTX. Population pharmacokinetics of MTX analysis was performed by using nonlinear mixed effects modeling.
Read the detailed description
- Methotrexate (MTX) is one of the critical components for treating all forms of acute lymphoblastic leukemia (ALL), which is the most common pediatric cancer. Unfortunately, high dose MTX has several undesirable side effects and MTX toxicity vastly differs from patient to patient.
- The pharmacokinetics of MTX were assessed with regards to the relevance of several different patient specific factors in 291 pediatric patients, who were administered with high dose of MTX. Population pharmacokinetics of MTX analysis was performed by using nonlinear mixed effects modeling.
- The final model was validated using nonparametric bootstrap analysis. Body surface area (BSA), pre-hydration, baseline serum creatinine and 24 h creatinine clearance rate were statistically significant covariates for distributional volume (V) and renal clearance (CL). Herein, is the first report of analysis of the importance of a series of patient factors on pharmacokinetics of MTX by one-compartment model. Using these data, we have established an efficient population pharmacokinetic model for MTX, which can be used to predict safe clinical application of MTX especially in children with ALL.
- Conditions
- Methotrexate Adverse Reaction
- Being tested
- 3g MTX, 5g MTX
- Keywords
- Methotrexate,, Pharmacokinetic, Acute lymphoblastic leukemia, Model
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3g MTXDrug
The group of patients which are treated with 3g/m2 MTX, low risk ALL or NHL
5g MTXDrug
The group of patients which are treated with 5g/m2 MTX, they are high or middle risk ALL patients
| Study group | Role | What they receive |
|---|---|---|
| 3g group | Experimental | The dose of MTX is 3 g/m2 Receives: Drug: 3g MTX |
| 5g group | Experimental | The dose of MTX is 5g/m2 Receives: Drug: 5g MTX |
What is being measured
The primary outcome is the main question the study is designed to answer.
elimination delay
The serum MTX is higher than 1umol/L in 48 hours or 0.1umol/L in 96 hours
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startMay 2009
- Primary completionDec 2009
- Study completionFeb 2010
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 Methotrexate Adverse ReactionStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiqun Xu, The Children's Hospital of Zhejiang University School of Medicine
- Investigators
- Weiqun Xu, Principal investigator, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011022
- Sponsor's protocol ID
- chzj-HDMTX-20131205
- Acronym
- HDMTX
- Status last verified
- Dec 2013
- First submitted
- 5 Dec 2013
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Yanagimachi M, Goto H, Kaneko T, Naruto T, Sasaki K, Takeuchi M, Tanoshima R, Kato H, Yokosuka T, Kajiwara R, Fujii H, Tanaka F, Goto S, Takahashi H, Mori M, Kai S, Yokota S. Influence of pre-hydration and pharmacogenetics on plasma methotrexate concentration and renal dysfunction following high-dose methotrexate therapy. Int J Hematol. 2013 Dec;98(6):702-7. doi: 10.1007/s12185-013-1464-z. Epub 2013 Nov 16.
PubMed 24241962
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Analysis of High Dose Methotrexate in Pediatric Acute Lymphoblastic Leukemia: Significant Impact Factors and Establishment of a Clinically Relevant Model
- ClinicalTrials.gov ID
- NCT02011022
- Acronym / sponsor ID
- HDMTX / chzj-HDMTX-20131205
- Conditions
- Methotrexate Adverse Reaction
- Keywords
- Methotrexate,, Pharmacokinetic, Acute lymphoblastic leukemia, Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 13 Dec 2013 (estimated)
- 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 pharmacokinetics of MTX were assessed with regards to the relevance of several different patient specific factors in 291 pediatric patients, who were administered with high dose of MTX. Population pharmacokinetics of MTX analysis was performed by using nonlinear mixed effects modeling.
Detailed description
- Methotrexate (MTX) is one of the critical components for treating all forms of acute lymphoblastic leukemia (ALL), which is the most common pediatric cancer. Unfortunately, high dose MTX has several undesirable side effects and MTX toxicity vastly differs from patient to patient.
- The pharmacokinetics of MTX were assessed with regards to the relevance of several different patient specific factors in 291 pediatric patients, who were administered with high dose of MTX. Population pharmacokinetics of MTX analysis was performed by using nonlinear mixed effects modeling.
- The final model was validated using nonparametric bootstrap analysis. Body surface area (BSA), pre-hydration, baseline serum creatinine and 24 h creatinine clearance rate were statistically significant covariates for distributional volume (V) and renal clearance (CL). Herein, is the first report of analysis of the importance of a series of patient factors on pharmacokinetics of MTX by one-compartment model. Using these data, we have established an efficient population pharmacokinetic model for MTX, which can be used to predict safe clinical application of MTX especially in children with ALL.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3g group | Experimental | Drug: 3g MTXThe dose of MTX is 3 g/m2 |
| 5g group | Experimental | Drug: 5g MTXThe dose of MTX is 5g/m2 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Acute lymphoblastic leukemia and non-hodgkin's lymphoma younger than 18 years old
Key exclusion criteria (1 listed)
- Non lymphoblastic malignancies or older than 18 years
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 |
|---|---|---|
| 3g MTXThe group of patients which are treated with 3g/m2 MTX, low risk ALL or NHL | Drug | 3g group |
| 5g MTXThe group of patients which are treated with 5g/m2 MTX, they are high or middle risk ALL patients | Drug | 5g group |
Primary outcome
elimination delay
Time frame: 3 days
The serum MTX is higher than 1umol/L in 48 hours or 0.1umol/L in 96 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
- Background: PubMed 24241962Yanagimachi M, Goto H, Kaneko T, Naruto T, Sasaki K, Takeuchi M, Tanoshima R, Kato H, Yokosuka T, Kajiwara R, Fujii H, Tanaka F, Goto S, Takahashi H, Mori M, Kai S, Yokota S. Influence of pre-hydration and pharmacogenetics on plasma methotrexate concentration and renal dysfunction following high-dose methotrexate therapy. Int J Hematol. 2013 Dec;98(6):702-7. doi: 10.1007/s12185-013-1464-z. Epub 2013 Nov 16.
- Another related articleLink provided by the sponsor.
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.
Weiqun Xu principal investigator
The Children's Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3g MTX and 5g MTX in people with Methotrexate Adverse Reaction, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Dec 2013. 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
elimination delay (time frame: 3 days). 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 NCT02011022, 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 13 Dec 2013.