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

Phase 3

Completed

Conditions: cancer from the bone marrow
Leukemia
10024324
10019815

Registration Number: NL-OMON47149

Lead Sponsor: Stichting Kinderoncologie Nederland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 770

Inclusion Criteria

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

Exclusion Criteria

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Primary endpoints are survival, EFS, CIR, death in induction, death in<br /><br>remission and toxicity.<br /><br>2. Primary endpoint is the number of allergic reactions/silent inactivation;<br /><br>secondary endpoints are toxicity, EFS and survival.<br /><br>3. Primary endpoint is the number of infectious episodes for which patients are<br /><br>admitted to the hospital and receive therapeutic antibiotics or antifungals.<br /><br>4. Primary endpoint is the number of patients with allergic reaction or silent<br /><br>inactivation to PEGasparaginase and who are therefore switched to Erwinase.<br /><br>Secondary endpoints are the average cumulative dose of PEGasparaginase<br /><br>administered to patients in the MR arm A compared to the historical control of<br /><br>the ALL-10 MR study.</p><br>

Secondary Outcome Measures