International cooperative prospective study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine - ALCL-VB

GPOH gGmbH0 个研究点目标入组 132 人开始时间: 2022年11月10日最近更新: 2024年7月22日

研究概览

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•Stratification into the standard risk group (SR) by screening: Newly diagnosed ALK-positive ALCL, Stage I not completely resected, or stage II or stage III, MDD negative, Age < 18 years, Informed consent of the parents/legal guardians (and assent of the competent child) for study participation and data collection, storage and handling given before study entry, Participation in national / study group's reference pathology, Follow-up for at least 3 years after enrolment is expected, Application of a highly effective contraceptive method (Pearl index <1) in sexually active patients, Application of one intrathecal triple therapy with Methotrexate, Cytarabine and Prednisolone (or Hydrocortisone respectively) before start of the protocol treatment

•Progressive disease during a possible clinically indicated pre-phase treatment before inclusion in the study, Steroids for more than 2 days or chemotherapy pre-treatment before taking the screening sample for MDD, Chemotherapy pre-treatment before start of the study treatment except for: the obligatory initial intrathecal triple therapy with Methotrexate, Cytarabine and Prednisolone (or Hydrocortisone respectively), a possible clinically indicated pre-phase including up to 5 days of steroids combined with up to 3 doses of Vinblastine (and up to 2 doses of Cyclophosphamide), Pregnancy or lactation period, Contraindications for the treatment with Vinblastine: hypersensitivity against VBL or other vinca-alkaloids, leukopenia, other than in the context of the ALCL, severe uncontrolled infection, Other medical, psychiatric, familial or social condition prohibiting treatment according to the protocol

发起方

GPOH gGmbH