NCT01305655

Brief Summary

Early intervention in children and adolescents who experience delayed MTX-clearance and renal dysfunction in ALL treatments with the enzyme Glucarpidase which rapidly hydrolyses MTX to non-toxic metabolites to avoid life threatening complications.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_3

Geographic Reach
5 countries

5 active sites

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

Study Start

First participant enrolled

July 1, 2008

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

February 3, 2017

Completed
Last Updated

September 28, 2018

Status Verified

August 1, 2018

Enrollment Period

6.4 years

First QC Date

February 28, 2011

Results QC Date

October 17, 2016

Last Update Submit

August 31, 2018

Conditions

Acute Lymphoblastic Leukemia (ALL)

Keywords

Drug: Glucarpidase

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    6 years 6 months

Study Arms (1)

Glucarpidase arm

EXPERIMENTAL

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.

Drug: Glucarpidase

Interventions

GlucarpidaseDRUG

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.

Also known as: VORAXAZE®
Glucarpidase arm

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children and adolescents who experience delayed MTX-clearance and renal dysfunction during high-dose methotrexate treatment in NOPHO ALL-2008.

You may not qualify if:

  • Children and adolescents with earlier anaphylactic reaction to Glucarpidase. Pregnant patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Pediatrics, Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Helsinki University Hospital

Helsinki, Finland

Location

University of Reykjavik

Reykjavik, Iceland

Location

University Hospital of Trondheim

Trondheim, Norway

Location

Department of Pediatrics, Drottning Sylvias Pediatric Hospital

Gothenburg, Sweden

Location

Related Publications (1)

  • Svahn T, Mellgren K, Harila-Saari A, Asberg A, Kanerva J, Jonsson O, Vaitkeviciene G, Stamm Mikkelssen T, Schmiegelow K, Heldrup J. Delayed elimination of high-dose methotrexate and use of carboxypeptidase G2 in pediatric patients during treatment for acute lymphoblastic leukemia. Pediatr Blood Cancer. 2017 Jul;64(7). doi: 10.1002/pbc.26395. Epub 2016 Dec 14.

    PMID: 27966809DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

glucarpidase

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr Jesper Heldrup
Organization
NOPHO
jesper.heldrup@skane.se
+46705172389

Study Officials

  • Jesper Heldrup, M D

    University Childrens hospital, Lund, Sweden

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 1, 2011

Study Start

July 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 28, 2018

Results First Posted

February 3, 2017

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

Publication in preparation in Pediatric Blood and Cancer

Locations

FI(1)DK(1)SE(1)NO(1)IC(1)