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 : February 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia (ALL)||Drug: Glucarpidase||Phase 3|
The NOPHO ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and with the aim to reduce and prevent toxic treatment complications with high-dose methotrexate (HD-MTX).
The specific and primary objectives of the randomized study is:
- Early intervention in children and adolescents who experience delayed MTX-clearance and renal dysfunction with the enzyme Glucarpidase which rapidly hydrolyses MTX to non-toxic metabolites and lowers the serum concentration to avoid life threatening complications. Glucarpidase should be given 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. Glucarpidase treatment should take place within 48 hours from the start of HD-MTX treatment.
- To evaluate if the early intervention with Glucarpidase reduce the number of days the patients have to stay at the hospital.
- Evaluate the reduction of health costs of early intervention in patients with delayed MTX-clearance and renal dysfunction.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Glucarpidase (CPG2) Effect on Severe Delayed Methotrexate-clearance in Children Treated With High-dose Methotrexate in Acute Lymphoblastic Leukemia (ALL)|
|Study Start Date :||July 2008|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
Experimental: Glucarpidase arm
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.
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.
Other Name: VORAXAZE®
- 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. [ Time Frame: 6 years 6 months ]
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.
- Evaluate Time at Hospital and Health Costs [ Time Frame: 6 years 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305655
|Department of Pediatrics, Rigshospitalet|
|Copenhagen, Denmark, DK-2100|
|Helsinki University Hospital|
|University of Reykjavik|
|University Hospital of Trondheim|
|Department of Pediatrics, Drottning Sylvias Pediatric Hospital|
|Principal Investigator:||Jesper Heldrup, M D||University Childrens hospital, Lund, Sweden|