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ALL11

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 mutat...

General Design

Type
Clinical trial
Data collection type
Prospective
Design
Longitudinal
Design 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.
Start/End data collection
2012 until 2020
Design papers
PID
https://doi.org/10.71739/qmkv-2895
External identifiers
METc number: 2012-287

Population

Countries
Netherlands (the)
Number of participants
887
Population age groups
Infants and toddlers (2-23 months), Adolescent (13-17 years), Young adult (18-24 years)
Main medical condition
  • II Neoplasms
Inclusion criteria
  • Age group inclusion criterion
  • Health status inclusion criterion
Other inclusion criteria
Child (1-19 years)

Organisations

Lead organisations

Contributors

Available Data & Samples

Data categories

  • Biological samples
  • Medical records

Sample categories

  • Blood
  • Cells

Areas of information

  • Symptoms and signs
  • Medication and supplements
  • Death
  • Physical measures and assessments
  • Laboratory measures

Subpopulations

List of subpopulations for this resource...

No results for current selection

Collection events

List of collection events defined for this resource...

No results for current selection

Networks

Part of networks...

  • Health data space Utrecht

    Welkom bij Health Data Space Utrecht, het portaal dat de regio Utrecht verbindt door onderzoekers en professionals samen te brengen om kennis en data te delen....

Publications

Continuous PEGasparaginase Dosing Reduces Hypersensitivity Reactions in Pediatric ALL: A Dutch Childhood Oncology Group ALL11 Randomized Trial
Immunoglobulin prophylaxis prevents hospital admissions for fever in pediatric acute lymphoblastic leukemia: results of a multicenter randomized trial
Improved Outcome for ALL by Prolonging Therapy for IKZF1 Deletion and Decreasing Therapy for Other Risk Groups

Access conditions

Data access conditions
  • health or medical or biomedical research
  • disease specific research
Data access fee
false
Prelinked
false

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