Glucarpidase (CPG2) Effect on Severe Delayed Methotrexate-clearance in Children Treated Wih High-dose Methotrexate in Acute Lymphoblastic Leukemia (ALL) (NOPHOCPG2)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Glucarpidase (CPG2) Effect on Severe Delayed Methotrexate-clearance in Children Treated With High-dose Methotrexate in Acute Lymphoblastic Leukemia (ALL)|
- 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 ] [ Designated as safety issue: Yes ]
- Evaluate time at hospital and health costs [ Time Frame: 6 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
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 > 20 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.
|Contact: Jesper Heldrup, M.D.||+firstname.lastname@example.org|
|Contact: Arja Harila-Saari, M.D. Ph.Demail@example.com|
|Department of Pediatrics, Rigshospitalet||Recruiting|
|Copenhagen, Denmark, DK-2100|
|Contact: Kjeld Schmiegelow, M.D. +45 35451357 firstname.lastname@example.org|
|Principal Investigator: Kjeld Schmiegelow, M.D.|
|Helsinki University Hospital||Recruiting|
|Contact: Kim Vettenranta, M.D. + 35 850-3676528 email@example.com|
|Principal Investigator: Kim Vettenranta, M.D.|
|University of Reykjavik||Recruiting|
|Contact: Olafur Jonsson, M.D. +354 5431000 firstname.lastname@example.org|
|Principal Investigator: Olafur Jonsson, M.D.|
|University Hospital of Trondheim||Recruiting|
|Contact: Ann Åsberg, M.D. + 47 92626432 email@example.com|
|Principal Investigator: Ann Åsberg, M.D.|
|Department of Pediatrics, Drottning Sylvias Pediatric Hospital||Recruiting|
|Contact: Jonas Abrahamson,, M.D. +46 707695159 firstname.lastname@example.org|
|Principal Investigator: Jonas Abrahamson, M.D.|