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

Trial details

Who runs it

Medical University Of Silesia Katowice Poland

Trial code

EU 2024-517253-27-00

Record updated

2024. október 28.

Original description

(1a) Randomization R-eHR: In children with early high-risk (early HR) pB-ALL defined by genetics and/or inadequate treatment response over the course of induction: Can the pEFS from time of randomization be improved by additional therapy with the proteasome inhibitor Bortezomib during an extended consolidation treatment phase compared with standard extended consolidation? (2a) Randomization R-HR: In children with high-risk (HR) pB-ALL defined by genetics and/or inadequate treatment response by the end of consolidation: Can the immunotherapy with Blinatumomab (three cycles, 15 μg/m²/d for 28 days per cycle) plus 6 doses intrathecal Methotrexate decrease the frequency of life-threatening treatment-related toxicities without decreasing the frequency of achieving negative MRD compared with standard post-consolidation chemotherapy (HR blocks) regimen?Read full original descriptionShow less

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.

(1a) Randomization R-eHR: In children with early high-risk (early HR) pB-ALL defined by genetics and/or inadequate treatment response over the course of induction: Can the pEFS from time of randomization be improved by additional therapy with the proteasome inhibitor Bortezomib during an extended consolidation treatment phase compared with standard extended consolidation? (2a) Randomization R-HR: In children with high-risk (HR) pB-ALL defined by genetics and/or inadequate treatment response by the end of consolidation: Can the immunotherapy with Blinatumomab (three cycles, 15 μg/m²/d for 28 days per cycle) plus 6 doses intrathecal Methotrexate decrease the frequency of life-threatening treatment-related toxicities without decreasing the frequency of achieving negative MRD compared with standard post-consolidation chemotherapy (HR blocks) regimen?

Inclusion: 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.

Exclusion: 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 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; 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.

EU CTIS 2024-517253-27-00