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 sites132 target enrollmentStarted: November 10, 2022Last updated: July 22, 2024

Overview

No summary available.

•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

Sponsor

GPOH gGmbH