Ruxolitinib for childhood ALL in Poland (Rux-cALL-Pol 2020 trial) - Single-arm interventional study with ruxolitinib and AIEOP-BFM 2017 Poland or AIEOP-BFM 2017 standard of care chemotherapy in children with acute lymphoblastic leukemia and confirmed activation of JAK/STAT pathway.

Medical University Of Lodz15 sites in 1 country25 target enrollmentNovember 18, 2024

Overview

Compare the rate of MRD(-) at TP2 in ruxolitinib + Consol. IB ext. to appropriate external control.

Registry

euclinicaltrials.eu

Start Date

November 18, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sponsor

Responsible Party

Principal Investigator

Wojciech Młynarski

Scientific

Medical University Of Lodz

•Newly diagnosed ALL treated according to AIEOP-BFM 2017 Poland or AIEOP-BFM 2017 standard of care protocol.
•Confirmed genetic lesion causing activation of JAK-STAT pathway (CRLF2, JAK2, EPOR, or CRLF2 expression on leukemic cells`surface).
•Stratification as early high risk: - no complete remission on day 33 OR - positivity for KMT2A-AFF1 OR - positivity for TCF3-HLF OR o hypodiploidy <45 chromosomes OR - FCM-MRD in bone marrow on day 15 ≥ 10% and not ETV6-RUNX1 positive OR - IKZF1plus and PCR-MRD at TP1 positive or inconclusive and not positive for ETV6-RUNX1, TCF3-PBX1 or KMT2A rearr. other than KMT2A-AFF1 OR - PCR-MRD at TP1 ≥ 5x10-4 OR -age < 1 year and any KMT2A rearrangement

•ALL classified as a standard or intermediate risk (SR, MR).
•Early high risk (eHR) ALL without genetic lesions within CRLF2, JAK2, EPOR, or CRLF2 expression on leukemic cells.
•Participation in another clinical trial except for ad-on trials within the scope of supportive care approved by the sponsor
•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

Proportion of patients with MRD(-) at TP2.

Frequency and grading of adverse events in Consol. IB ext. phase (number, percentage, number per patient-days, number per each grade of significance).
Incidence of treatment-related adverse and severe adverse events.