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

Phase 1

Conditions: acute lymphoblastic leukemia in children and adolescents
MedDRA version: 21.0Level: LLTClassification code: 10000844Term: Acute lymphoblastic leukaemia Class: 10029104
Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-509856-32-00

Lead Sponsor: niversitaetsklinikum Schleswig-Holstein

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 5100

Inclusion Criteria

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

Exclusion Criteria

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