AIEOP-BFM 2017 POLAND - Collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia - A randomized phase III study conducted in agreement with the AIEOP-BFM study group

Prior treatment

• live vaccine immunization within 2 weeks before start of protocol treatment
• 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
• Sexually active adolescents not willing to use highly effective contraceptive method (Pearl Index <1) until 12 months after end of anti-leukemic therapy

Other illness

• 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
• underlying disease that does not allow treatment according to the protocol
• ALL diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy

Other

• Ph+ (BCR::ABL1 or t(9;22)-positive) ALL
• participation in another clinical trial except for ad-on trials within the scope of supportive care approved by the sponsor
• bilineal leukemia with a lymphoblastic and a separate non-lymphoblastic (≥ 10% of total cells) blast subset
• treatment started according to another protocol
• evidence of pregnancy or lactation period

• newly diagnosed acute lymphoblastic leukemia or
• newly diagnosed acute undifferentiated leukemia or
• newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria: • biphenotypic with a dominant T or B lineage assignment • bilineal either with a dominant lymphoblastic population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen
• 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