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

Launched by MARTIN SCHRAPPE · Aug 20, 2018

Keywords

ClinConnect Summary

The AIEOP-BFM ALL 2017 clinical trial is studying new treatment options for children and teenagers diagnosed with acute lymphoblastic leukemia (ALL), a type of blood cancer. Researchers want to see how well a combination of traditional chemotherapy and new therapies, like immunotherapy with a drug called blinatumomab and a targeted treatment called bortezomib, work together to help patients. This trial aims to improve treatment for those at high risk of relapse, meaning the cancer could come back after treatment, and to reduce the side effects that can come from current chemotherapy methods.

To participate, patients must be under 18 years old and newly diagnosed with ALL or a specific type of mixed leukemia. They should not have received prior treatment for leukemia or have certain other health conditions. Families can expect close monitoring and personalized care throughout the study, with the hope that these new treatment options will lead to better outcomes and fewer side effects for their children. It’s important to know that the study is actively recruiting participants, and those enrolled will be contributing to important research that may help improve treatments for future patients.

Gender

ALL

Eligibility criteria

• 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