AIEOP-BFM ALL 2017 - International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia - AIEOP-BFM_ALL_2017

niversitaetsklinikum Schleswig-Holstein0 个研究点目标入组 5,100 人开始时间: 2024年5月30日最近更新: 2024年7月22日

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•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

•Ph+ (BCR-ABL1 or t(9;22)-positive) ALL, 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, bilineal leukemia with a lymphoblastic and a separate nonlymphoblastic (= 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 antileukemic therapy

发起方

niversitaetsklinikum Schleswig-Holstein