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.
- Conditions
- Acute lymphoblastic leukemia
- Registration Number
- 2024-518316-39-00
- Lead Sponsor
- Medical University Of Lodz
- Brief Summary
Compare the rate of MRD(-) at TP2 in ruxolitinib + Consol. IB ext. to appropriate external control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 25
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with MRD(-) at TP2. Proportion of patients with MRD(-) at TP2.
- Secondary Outcome Measures
Name Time Method Frequency and grading of adverse events in Consol. IB ext. phase (number, percentage, number per patient-days, number per each grade of significance). 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. Incidence of treatment-related adverse and severe adverse events.
Trial Locations
- Locations (15)
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku
🇵🇱Bialystok, Poland
Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie
🇵🇱Szczecin, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy Im. Prof. Dr Stanislawa Popowskiego W Olsztynie Sp. z o.o.
🇵🇱Olsztyn, Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
🇵🇱Kielce, Poland
Uniwersytecki Szpital Dzieciecy W Lublinie
🇵🇱Lublin, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
🇵🇱Zabrze, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
🇵🇱Lodz, Poland
Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie
🇵🇱Rzeszow, Poland
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
🇵🇱Wroclaw, Poland
Scroll for more (5 remaining)Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku🇵🇱Bialystok, PolandMaryna Krawczuk-RybakSite contact+48857450846maryna.krawczuk-rybak@umb.edu.pl