PROTOCOL ALL 11: Treatment study protocol of the Dutch Childhood Oncology Group for Children and adolescents (1-19 year) with newly diagnosed acute lymphoblastic leukemia

  1. To improve the overall outcome as compared to the previous protocols of the DCOG, especially ALL-9 and ALL-10. This is aimed for by decreasing therapy for part of the patients (TEL/AML1, Down syndrome, PPR only), increasing therapy for IKZF1 mutated cases, decreasing the cumulative dose of anthracyclines, omitting cranial irradiation and total body irradiation and individualizing asparaginase therapy for all patients. 2. Does a continuous schedule of Asparaginase lead to less allergic reaction/inactivation of Asparaginase than the standard non continuous schedule of Asparaginase? Patients are randomized to receive noncontinuous PEGasparaginase in IA (induction) and intensification of the Medium Risk group (standard arm A) or to receive continuous PEGasparaginase in IA, IB, M and intensification (continuous arm B) with the same cumulative number of doses of PEGasparaginase. 3. Does prophylactic administration of intravenous immunoglobulins reduce the number of infections during the intensive treatment phases? Patients are randomized in the induction and MR treatment group to receive or not receive prophylactic immunoglobulins. 4. Individualize the dose schedule of asparaginase by therapeutic drug monitoring in order to detect silent inactivation of asparaginase, to prevent allergic/anaphylactic reactions, to switch Asparaginase preparation in time and to prevent too high levels with possible toxicity.

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Titel PROTOCOL ALL 11: Treatment study protocol of the Dutch Childhood Oncology Group for Children and adolescents (1-19 year) with newly diagnosed acute lymphoblastic leukemia
Omschrijving
  1. To improve the overall outcome as compared to the previous protocols of the DCOG, especially ALL-9 and ALL-10. This is aimed for by decreasing therapy for part of the patients (TEL/AML1, Down syndrome, PPR only), increasing therapy for IKZF1 mutated cases, decreasing the cumulative dose of anthracyclines, omitting cranial irradiation and total body irradiation and individualizing asparaginase therapy for all patients. 2. Does a continuous schedule of Asparaginase lead to less allergic reaction/inactivation of Asparaginase than the standard non continuous schedule of Asparaginase? Patients are randomized to receive noncontinuous PEGasparaginase in IA (induction) and intensification of the Medium Risk group (standard arm A) or to receive continuous PEGasparaginase in IA, IB, M and intensification (continuous arm B) with the same cumulative number of doses of PEGasparaginase. 3. Does prophylactic administration of intravenous immunoglobulins reduce the number of infections during the intensive treatment phases? Patients are randomized in the induction and MR treatment group to receive or not receive prophylactic immunoglobulins. 4. Individualize the dose schedule of asparaginase by therapeutic drug monitoring in order to detect silent inactivation of asparaginase, to prevent allergic/anaphylactic reactions, to switch Asparaginase preparation in time and to prevent too high levels with possible toxicity.
Keywords
Contact points
Contact point 1
URI
http://catalogue.hdsu.nl/catalogue-rdf/api/rdf/Contacts/firstName=Hester&lastName=de%20Groot-Kruseman&resource=ALL11
Naam
Hester de Groot-Kruseman
Name (translations)
Email
TDCSecretary@prinsesmaximacentrum.nl
Identifier
URL
    Publisher
    Publisher 1
    URI
    http://catalogue.hdsu.nl/catalogue-rdf/api/rdf/Agents/id=PMC&resource=ALL11
    Naam
    Princess Máxima Center
    Name (translations)
    Email
    info@prinsesmaximacentrum.nl
    URL
    https://www.prinsesmaximacentrum.nl
    Type
    Publisher note
    Publisher type
    Identifier
    https://ror.org/02aj7yc53
    Creator
    Creator 1
    URI
    http://catalogue.hdsu.nl/catalogue-rdf/api/rdf/Agents/id=PMC&resource=ALL11
    Naam
    Princess Máxima Center
    Name (translations)
    Email
    info@prinsesmaximacentrum.nl
    URL
    https://www.prinsesmaximacentrum.nl
    Type
    Publisher note
    Publisher type
    Identifier
    https://ror.org/02aj7yc53
    Landing page
    Release date
    Modification date
    In Series
      Versie
      Version notes
      Identifier https://doi.org/10.71739/qmkv-2895
      Frequency
      Provenance
      1. To improve the overall outcome as compared to the previous protocols of the DCOG, especially ALL-9 and ALL-10. This is aimed for by decreasing therapy for part of the patients (TEL/AML1, Down syndrome, PPR only), increasing therapy for IKZF1 mutated cases, decreasing the cumulative dose of anthracyclines, omitting cranial irradiation and total body irradiation and individualizing asparaginase therapy for all patients. 2. Does a continuous schedule of Asparaginase lead to less allergic reaction/inactivation of Asparaginase than the standard non continuous schedule of Asparaginase? Patients are randomized to receive noncontinuous PEGasparaginase in IA (induction) and intensification of the Medium Risk group (standard arm A) or to receive continuous PEGasparaginase in IA, IB, M and intensification (continuous arm B) with the same cumulative number of doses of PEGasparaginase. 3. Does prophylactic administration of intravenous immunoglobulins reduce the number of infections during the intensive treatment phases? Patients are randomized in the induction and MR treatment group to receive or not receive prophylactic immunoglobulins. 4. Individualize the dose schedule of asparaginase by therapeutic drug monitoring in order to detect silent inactivation of asparaginase, to prevent allergic/anaphylactic reactions, to switch Asparaginase preparation in time and to prevent too high levels with possible toxicity.
      Type
      Temporal coverage
      Temporal resolution
      Spatial coverage
      Spatial coverage 1
      URI
      http://publications.europa.eu/resource/authority/country/NLD
      Label
      Geometry
      Bounding Box
      Centroid
      Spatial resolution in meters
      Access rights http://publications.europa.eu/resource/authority/access-right/NON_PUBLIC
      Other identifier
      Theme
      1. http://publications.europa.eu/resource/authority/data-theme/HEAL
      Taal
      Documentation
      Conforms to
      Is referenced by
      Distribution
      Sample
      Analytics
      Applicable legislation
      1. http://data.europa.eu/eli/reg/2022/868/oj
      Has version
      Code values
      Coding system
      Purpose
      Health category
      Health theme
      Legal basis
      Minimum typical age
      Maximum typical age
      Number of records
      Number of records for unique individuals. 887
      Personal data
      Publisher note
      Publisher type
      Trusted Data Holder
      Population coverage
      Retention period
      Health data access body
      Qualified relation
      Provenance activity
      Qualified attribution
      Quality annotations
      URI http://catalogue.hdsu.nl/catalogue-rdf/api/rdf/Resources/id=ALL11