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

Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH) gGmbH0 个研究点目标入组 106 人开始时间: 2021年10月15日最近更新: 2022年4月25日

研究概览

暂无简介。

•Stratification into the standard risk group (SR) by screening:
•o Newly diagnosed ALK-positive ALCL
•o Stage I not completely resected, or stage II or stage III
•o 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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 106
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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
•o the obligatory initial intrathecal triple therapy with Methotrexate, Cytarabine and Prednisolone (or Hydrocortisone respectively)
•o 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:
•o hypersensitivity against VBL or other vinca-alkaloids
•o leukopenia, other than in the context of the ALCL
•o severe uncontrolled infection
•Other medical, psychiatric, familial or social condition prohibiting treatment according to the protocol

发起方

Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH) gGmbH