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

This study has been completed.
Sponsor:
Collaborator:
Lund University Hospital
Information provided by (Responsible Party):
Jesper Heldrup, Nordic Society for Pediatric Hematology and Oncology
ClinicalTrials.gov Identifier:
NCT01305655
First received: February 28, 2011
Last updated: December 10, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Acute Lymphoblastic Leukemia (ALL)
Drug: Glucarpidase
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group 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)

Resource links provided by NLM:


Further study details as provided by Nordic Society for Pediatric Hematology and Oncology:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • Evaluate Time at Hospital and Health Costs [ Time Frame: 6 years 6 months ]

Enrollment: 47
Study Start Date: July 2008
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: 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.
Other Name: VORAXAZE®

Detailed Description:

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:

  1. 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.
  2. To evaluate if the early intervention with Glucarpidase reduce the number of days the patients have to stay at the hospital.
  3. Evaluate the reduction of health costs of early intervention in patients with delayed MTX-clearance and renal dysfunction.
  Eligibility

Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305655

Locations
Denmark
Department of Pediatrics, Rigshospitalet
Copenhagen, Denmark, DK-2100
Finland
Helsinki University Hospital
Helsinki, Finland
Iceland
University of Reykjavik
Reykjavik, Iceland
Norway
University Hospital of Trondheim
Trondheim, Norway
Sweden
Department of Pediatrics, Drottning Sylvias Pediatric Hospital
Goteborg, Sweden
Sponsors and Collaborators
Nordic Society for Pediatric Hematology and Oncology
Lund University Hospital
Investigators
Principal Investigator: Jesper Heldrup, M D University Childrens hospital, Lund, Sweden
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jesper Heldrup, MD, Nordic Society for Pediatric Hematology and Oncology
ClinicalTrials.gov Identifier: NCT01305655     History of Changes
Other Study ID Numbers: NOPHO2008CPG2
Study First Received: February 28, 2011
Results First Received: October 17, 2016
Last Updated: December 10, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Publication in preparation in Pediatric Blood and Cancer

Keywords provided by Nordic Society for Pediatric Hematology and Oncology:
Drug: Glucarpidase

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 24, 2017