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Trial record 17 of 325 for:    "Acute Lymphocytic Leukemia" | "Methotrexate"

Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL (NOPHOCPG2)

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ClinicalTrials.gov Identifier: NCT01305655
Recruitment Status : Completed
First Posted : March 1, 2011
Results First Posted : February 3, 2017
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
Lund University Hospital
Information provided by (Responsible Party):
Jesper Heldrup, Nordic Society for Pediatric Hematology and Oncology

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Lymphoblastic Leukemia (ALL)
Intervention Drug: Glucarpidase
Enrollment 47
Recruitment Details From July 2008 children treated with the NOPHO ALL 2008 protocol (1-18 years) in the Nordic- and Baltic countries received Glucarpidase if they had delayed Mtx elimination in connection HDMTX 5 g/sqr at predefined values.
Pre-assignment Details  
Arm/Group Title Glucarpidase Arm
Hide Arm/Group Description In children treated with high dose MTX (HDMTX) according to the NOPHO ALL 2008 protocol, Glucarpidase was used in case of predefined toxic MTX values at defined time points in combination with decreased renal function.
Period Title: Overall Study
Started 47 [1]
Completed 47 [2]
Not Completed 0
[1]
July 2008
[2]
December 31, 2014
Arm/Group Title Glucarpidase Arm
Hide Arm/Group Description

In the NOPHO ALL-2008 protocol patients with delayed methotrexate elimination (DME) in high-dose methotrexate treatments should be given Glucarpidase (50 ie/kg) with-in 60 hours from start of the methotrexate treatment.

Glucarpidase: Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values.

Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
<=18 years
47
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous   [1] 
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants
7.5  (4.89)
[1]
Measure Description: Children 1-18 years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
20
  42.6%
Male
27
  57.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
Sweden 14
Norway 16
Finland 1
Denmark 11
Iceland 2
Lithuania 3
1.Primary Outcome
Title Number of Participants With Adverse Event to HD-MTX Treatment in NOPHO ALL-2008 as a Measure of Toxic Mtx Concentrations in Blood, Nephrotoxicity, Hepatotoxicity, Mucositis, MTX Elimination Time and Permanent Kidney Damage.
Hide Description

Glucarpidase was used in case of predefined toxic MTX values at defined time points and/or in combination with decreased renal function.

A total of 47 patients of the 1286 ALL-patients included in the protocol (3.7 %) were treated with Glucarpidase.

Time Frame 6 years 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glucarpidase Arm
Hide Arm/Group Description:
47 children treated with high dose MTX (HDMTX) according to the NOPHO ALL 2008 protocol, Glucarpidase was used in case of predefined toxic MTX values at defined time points in combination with decreased renal function.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
47
Time Frame 6 year, 6 months
Adverse Event Reporting Description Non
 
Arm/Group Title Glucarpidase Arm
Hide Arm/Group Description

In the NOPHO ALL-2008 protocol patients with delayed methotrexate elimination (DME) in high-dose methotrexate treatments should be given Glucarpidase (50 ie/kg) with-in 60 hours from start of the methotrexate treatment.

Glucarpidase: Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values.

No serious effect reported.

All-Cause Mortality
Glucarpidase Arm
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Glucarpidase Arm
Affected / at Risk (%)
Total   0/47 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Glucarpidase Arm
Affected / at Risk (%)
Total   0/47 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Jesper Heldrup
Organization: NOPHO
Phone: +46705172389
EMail: jesper.heldrup@skane.se
Layout table for additonal information
Responsible Party: Jesper Heldrup, Nordic Society for Pediatric Hematology and Oncology
ClinicalTrials.gov Identifier: NCT01305655     History of Changes
Other Study ID Numbers: NOPHO2008CPG2
First Submitted: February 28, 2011
First Posted: March 1, 2011
Results First Submitted: October 17, 2016
Results First Posted: February 3, 2017
Last Update Posted: September 28, 2018