Treatment with chemotherapy for children >1 and <19 years of age with acute lymphoblastic leukemia.
- Conditions
- Acute lymphoblastic leukemia in childrenMedDRA version: 21.0Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-000067-25-NL
- Lead Sponsor
- Princess Máxima Center for pediatric oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 819
1.Newly diagnosed patients with T-lineage or precursor-B lineage ALL (patients with mature B-ALL are not eligible)
2.Age between = 1 and < 19 years
3.Informed consent signed by parents/guardians and patient if 12 years or older
4.Diagnosis ALL confirmed by DCOG laboratory
5.Patient should be treated in a Dutch Childhood Oncology Centre
6.Patient should be >3 months settled in The Netherlands at diagnosis
Are the trial subjects under 18? yes
Number of subjects for this age range: 818
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Age = 19 years at diagnosis
2.Age < 366 days at diagnosis (infant ALL); these patients are eligible for the Interfant protocol
3.Patients with secondary ALL
4.Patients with mature B-ALL (immunophenotypical or documented presence of karyotype t(8;14), t(2;8), t(8;22) and breakpoint as in B-ALL)
5.Patients with relapsed ALL
6.Pre-existing contra-indications for treatment according to (parts of) protocol ALL-11.
7.Essential data missing (in consultation with the protocol chairman)
8.Treatment with systemic corticosteroids and/or cytostatics in a 4-week interval prior to diagnosis. One exception is the use of corticosteroids as emergency treatment.
9.Patients with Ph-positive ALL (documented presence of t(9;22)(q34;q11) and/or of the BCR/ABL fusion transcript). These patients will be transferred to the EsPhALL protocol in induction according to the guidelines of the EsPhALL protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To treat children with ALL with the best available treatment as possible, based upon the risk factors of the patient at diagnosis.;Secondary Objective: Reduction of toxicity of treatment. <br>Reduction of allergic reactions on chemotherapy.<br>Reduction of infections during intensification of treatment. ;Primary end point(s): 1.Primary endpoint is survival.<br>2.Primary endpoint is the number of allergic reactions/silent inactivation of asparaginase. <br>3.Primary endpoint is the number of infectious episodes for which patients are admitted to the hospital and receive therapeutic antibiotics or antifungals.<br>4.Primary endpoint is the number of patients with allergic reaction or silent inactivation to PEGasparaginase and who are therefore switched to Erwinase. ;Timepoint(s) of evaluation of this end point: During interim analyses and also at the end of this protocol, expected in 2018.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1.Secondary endpoints are EFS, CIR, death in induction, death in remission and toxicity.<br>2.Secondary endpoints are toxicity, EFS and survival.<br>3.Secondary endpoint is 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.<br>;Timepoint(s) of evaluation of this end point: During interim analyses and also at the end of this protocol, expected in 2018.