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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Title 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
Description
  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
Name
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
Name
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
Name
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
Temporal start date
Temporal end date
In Series
    Version
    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
    Language
    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.
    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