Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

291

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started May 2009

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9 months study duration

Study Start

First participant enrolled

May 1, 2009

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed

3.8 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2013

Completed

8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed

Last Updated

December 13, 2013

Status Verified

December 1, 2013

Enrollment Period

7 months

First QC Date

December 5, 2013

Last Update Submit

December 10, 2013

Conditions

Methotrexate Adverse Reaction

Keywords

Methotrexate,PharmacokineticAcute lymphoblastic leukemiaModel

Outcome Measures

Primary Outcomes (1)

elimination delay
The serum MTX is higher than 1umol/L in 48 hours or 0.1umol/L in 96 hours
3 days

Study Arms (2)

3g group

EXPERIMENTAL

The dose of MTX is 3 g/m2

Drug: 3g MTX

5g group

EXPERIMENTAL

The dose of MTX is 5g/m2

Drug: 5g MTX

Interventions

3g MTXDRUG

The group of patients which are treated with 3g/m2 MTX, low risk ALL or NHL

3g group

5g MTXDRUG

The group of patients which are treated with 5g/m2 MTX, they are high or middle risk ALL patients

5g group

Eligibility Criteria

AgeUp to 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Acute lymphoblastic leukemia and non-hodgkin's lymphoma younger than 18 years old

You may not qualify if:

Non lymphoblastic malignancies or older than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

The Children's Hospital of Zhejiang University School of Medicinelead

Study Sites (1)

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

Location

Related Publications (1)

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.
PMID: 24241962BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

Weiqun Xu
The Children's Hospital of Zhejiang University School of Medicine
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Doctor

Study Record Dates

First Submitted

December 5, 2013

First Posted

December 13, 2013

Study Start

May 1, 2009

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

December 13, 2013

Record last verified: 2013-12

Locations

CN(1)

Pharmacokinetic Analysis of High Dose Methotrexate in Pediatric Lymphoblastic Malignancies

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

3g group

5g group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

3g group

5g group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations