Protocol ALL-11: Treatment study protocol for ALL in the Netherlands

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 - SKION ALL-11

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29675

Enrollment

630

Registered

2012-03-28

Start date

2012-11-09

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute lymfatische leukemie bij kinderen acute lymphoblastic leukemia in children

Interventions

IVIG (Nanogam) PEG-L-asparaginase (Oncospar)

Eligibility

Age

No minimum to 17 Years

Inclusion criteria

Inclusion criteria: 1. Nieuw gediagnostiseerde patienten met T- of precursor B ALL (patienten met Mature B-ALL zijn niet eligible) 2. Leeftijd tussen > 1 and < 19 years 3. Informed consent van ouders/verzorgers en patient (als 12 jaar of ouder) 4. Diagnose bevestigd door SKION laboratorium 5. Patient wordt behandeld binnen Kinderoncologisch centrum 6. Patient is > 3 maanden woonachtig in Nederland

Exclusion criteria

Exclusion criteria: 1. Leeftijd = 19 jaar bij diagnose 2. Leeftijd < 366 dagen bij diagnose (infant ALL) 3. Patienten met secundaire ALL 4. Patienten met mature B-ALL (immunologisch bevestigd of aanwezigheid van karyotype t(8;14), t(2;8), t(8;22) en fusieproduct als in B-ALL 5. Patienten met recidief ALL 6. Pre-existente contra-indicaties voor behandeling met (delen) protocol ALL11 7. Essentiele data ontbreken (in overleg met protocol Voorzitter) 8. Systemische behandeling met corticosteroiden en/of cytostatica in de 4-weken voorafgaand aan diagnose. Uitzondering is het gebruik van corticosteroiden als 'noodbehandeling'. 9. Patienten met Ph-positieve ALL (aanwezigheid t(9;22)(q34;q11) en/of aanwezigheid BCR-ABL fusietranscript). Deze patienten zullen behandeld worden volgens het EsPhALL protocol in de inductie, volgens de richtlijnen van het EsPhALL protocol.

Design outcomes

Primary

Measure	Time frame
1. Primary endpoints are survival, EFS, CIR, death in induction, death in remission and toxicity. 2. Primary endpoint is the number of allergic reactions/silent inactivation; secondary endpoints are toxicity, EFS and survival. 3. Primary endpoint is the number of admissions for fever and the number of courses with therapeutic antibiotics in both groups. 4. Primary endpoint is the number of patients with allergic reaction or silent inactivation to PEGasparaginase and who are therefore switched to Erwinase. Secondary endpoints are the average cumulative dose of PEGasparaginase administered to patients in the MR arm A compared to the historical control of the ALL-10 MR study.	—

Measure

Time frame

1. Primary endpoints are survival, EFS, CIR, death in induction, death in remission and toxicity. 2. Primary endpoint is the number of allergic reactions/silent inactivation; secondary endpoints are toxicity, EFS and survival. 3. Primary endpoint is the number of admissions for fever and the number of courses with therapeutic antibiotics in both groups. 4. Primary endpoint is the number of patients with allergic reaction or silent inactivation to PEGasparaginase and who are therefore switched to Erwinase. Secondary endpoints are the average cumulative dose of PEGasparaginase administered to patients in the MR arm A compared to the historical control of the ALL-10 MR study.

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Contacts

Public ContactProf. dr. R. Pieters

Prinses Máxima Centrum voor kinderoncologie

R.Pieters@prinsesmaximacentrum.nl088-972 72 72

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)