Nina Mogensen

AIMS: To improve treatment of children and adolescents with standard-risk (SR) ALK-positive anaplastic large cell lymphoma (ALCL) and significantly reduce treatment-related side effects. Primary aim: To demonstrate that 24 months of vinblastine (VBL) monotherapy can cure at least 75% of SR patients (pEFS 75%).Secondary aims: To investigate disease-free survival, overall survival, treatment mortality, and the frequency of disease relapse compared to traditional ALCL-99 multi-agent chemotherapy. To assess the likelihood that SR patients will require multi-agent chemotherapy. To examine the frequency and severity of adverse events related to VBL treatment. To evaluate treatment response through imaging studies at 3 weeks, 3 months, and 6 months from the start of treatment. BACKGROUND: ALCL is the third most common non-Hodgkin lymphomas and is lethal if not treated. The traditional treatment consists of combination chemotherapy, which permanently cures about 75% but is associated with both short- and long-term toxicity, including cardiotoxicity and risk of impaired fertility. This study investigates VBL treatment, administered weekly on an outpatient basis for 2y instead of traditional combination chemotherapy. VBL is effective in ALCL relapses, and has clearly fewer side effects compared to current standard treatment. This trial is being conducted across Europe. In Sweden approx 1-3 children/y are expected to be eligible for this study. The coordinating center for the study is the NHL-BFM Study Center in Hamburg, Germany. NOPHO has decided to participate, and Finland and Denmark have already opened this study. METHODS: -Blood sample for RT-PCR sent to Copenhagen (to evaluate if eligible or not) -VBL is admin at 6 mg/m² (max 10 mg) iv for a total of 24 months (weekly for 18 months, followed by every other week for the last 6 months). Radiology during treatment as per protocol. This trial could decrease toxicity for children with ALCL, without compromising survival.