Last updated on January 2020

Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: childhood ALL
  • Age: - 17 Years
  • Gender: Male or Female

Inclusion Criteria:

  • newly diagnosed acute lymphoblastic 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
  • 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 A subsequent removal from the study is only allowed if the inclusion criteria turn out not to be fulfilled or in the case of pregnancy of the patient.

Exclusion Criteria:

  • 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 for more than two weeks during the last month before diagnosis
  • treatment started according to another protocol
  • underlying disease that does not allow treatment according to the protocol (e.g. severe congenital heart disease, Charcot-Marie Syndrome, Ataxia-teleangiectasia)
  • 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 except for add-on trials within the scope of supportive care approved by the sponsor
  • live vaccine immunization within 2 weeks before start of protocol treatment

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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