The study is investigating ALK-positive anaplastic large-cell lymphoma (ALCL) in children and adolescents. ALCL belongs to the group of lymphomas (cancers of the lymph node) commonly referred to as non-Hodgkin lymphomas. Approximately 1-2 patients per year are expected to be enrolled in the study in Switzerland.
Without treatment, the lymphoma cells spread rapidly throughout the body. Therefore, treatment is essential. The existing standard treatment consists of combination therapy administered in several inpatient hospital stays over a period of five to six months.
The main aim of the study is to investigate whether treatment with Vinblastine in standard-risk patients achieves results that are at least as good as the existing standard treatment, with a substantial reduction in the occurrence of side effects and the risk of complications. The medication Vinblastine is administered on an outpatient basis every week for a two-year period. During outpatient treatment with Vinblastine, it should also be possible for patients to attend school, training or university, or to participate in employment.
The Society of Paediatric Oncologists and Haematologists (GPOH gGmbH) in Germany is responsible for the international implementation of the study (sponsor). The Swiss Paediatric Oncology Group (SPOG) is responsible for performing the study in Switzerland (sponsor’s representative).
In short
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The study is investigating standard-risk ALK-positive anaplastic large-cell lymphoma in children and adolescents. The existing standard treatment consists of combination chemotherapy and requires several inpatient hospital stays over a period of five to six months.
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The main aim of the study is to determine whether treatment with Vinblastine is at least as effective as the standard treatment and with fewer acute side effects and a lower risk of complications.
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Vinblastine may be administered in outpatient procedures, avoiding the need for long hospital stays and enabling patients to attend school or go to work as normal.
