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

Phase 3

Completed

Conditions: <p>Acute lymfatische leukemie bij kinderen acute lymphoblastic leukemia in children</p>
10024324

Brief Summary: The DCOG ALL11 showed that the five-year survival for children with acute lymphatic leukaemia increased to 94%. The ALL11 included 800 Dutch children and examined modified treatment protocols for four subgroups. The modifications were found to have a positive effect on survival and quality of life. The effect of modified treatment in specific groups of children with leukaemia, including those with a so-called Ikaros abnormality (IFZF1del), was examined. In this study, these children received an extra year of chemotherapy in the 'maintenance phase' on top of the first two years of treatment. This modification led to a nearly three times lower risk of cancer recurrence: it only happened in 9% of them, compared to 26% of children in the previous treatment protocol. In the ALL-11 protocol, doctors and researchers also looked at the effect of less intensive treatment for three other groups of children. These included children with a DNA abnormality in their leukaemia cells that is associated with a very high cure rate (ETV6::RUNX1), and children with Down's syndrome who suffer a lot of side effects from therapy. These children were given a lower amount of anthracyclines, a particular type of chemotherapy that increases the risk of heart damage and infections. The modification proved to be a good choice: the children had the same or even better survival rate while their quality of life improved due to a lower risk of infections and less risk of heart damage."

Recruitment & Eligibility

Inclusion Criteria

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1. Nieuw gediagnostiseerde patienten met T- of precursor B ALL (patienten met Mature B-ALL zijn niet eligible) |

Exclusion Criteria

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1. Leeftijd = 19 jaar bij diagnose |

Primary Outcome Measures

Name	Time	Method
<br><tr><br><td>1. Primary endpoints are survival, EFS, CIR, death in induction, death in remission and toxicity.<br /><br>2. Primary endpoint is the number of allergic reactions/silent inactivation; secondary endpoints are toxicity, EFS and survival.<br /><br>3. Primary endpoint is the number of admissions for fever and the number of courses with therapeutic antibiotics in both groups.<br /><br>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.</td><br></tr><br><br>

Secondary Outcome Measures