AIEOP-BFM ALL 2017 - International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia - AIEOP-BFM ALL 2017

niversitätsklinikum Schleswig-Holstein, Campus Kiel0 个研究点目标入组 5,000 人开始时间: 2019年1月23日最近更新: 2024年7月15日

适应症

试验速览

暂无简介。

•- newly diagnosed acute lymphoblastic leukemia, from 1st September 2023 onwards only acute lymphoblastic leukemia with T-cell phenotype or
•- newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria:
•biphenotypic with a dominant T or B lineage assignment,from 1st September 2023 onwards only those with a dominant T lineage assignment,
•bilineal either with a dominant lymphoblastic (from 1st September 2023 onwards only T lymphoblastic) population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen
•- newly diagnosed acute undifferentiated leukemia
•- age < 18 years (up to 17 years and 365 days) at the day of diagnosis
•- patient enrolled in a participating center
•- written informed consent to trial participation and transfer and processing of data
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 5000
•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

•- Ph+ (BCR-ABL1 or t(9;22)-positive) ALL
•- bilineal leukemia with a lymphoblastic and a separate non-lymphoblastic (= 10% of total cells) blast subset
•- pre-treatment with cytostatic drugs
•- glucocorticoid pre-treatment with = 1 mg/kg/d Prednisolone equivalent for more than two weeks during the last month before diagnosis
•- treatment started according to another protocol
•- underlying diseases that does not allow treatment according to the protocol
•- ALL diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
•- evidence of pregnancy or lactation period
•- Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
•- participation in another clinical trial that interferes with the protocol
•-other condition (either pre-existing or related to leukemia biology as present at diagnosis) or circumstances that significantly conflict with the treatment according to the protocol

发起方

niversitätsklinikum Schleswig-Holstein, Campus Kiel