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Taking people in PolandPhase 2/3

Tests ruxolitinib with chemotherapy in children with acute lymphoblastic leukemia

Tests ruxolitinib plus chemotherapy in children with leukemia and an overactive JAK/STAT pathway.

Key facts

Who runs it
Medical University Of Lodz
Where
Bialystok, Bydgoszcz, Cracow, Gdansk, Katowice, Kielce, Lodz, Lublin, Olsztyn, Poznan, Rzeszów, Szczecin, Warsaw, Wroclaw, and Zabrze, PolandSee the 15 sites
Registry title
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.
Status
Recruiting
Phase
Phase 2/3
People taking part
25 people, planned
Started
18 Nov 2024
Expected to end
4 May 2029
Type of study
Interventional
Record updated
4 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children with newly diagnosed acute lymphoblastic leukemia (ALL) in the early high-risk group, whose leukemia cells show activation of the JAK-STAT pathway.

Age
Up to 17 years old.
Sex
All sexes can join.
Disease stage
Newly diagnosed ALL treated with the AIEOP-BFM 2017 Poland or AIEOP-BFM 2017 standard of care protocol, and classed as early high risk.
Earlier treatment
The child must be treated under the AIEOP-BFM 2017 Poland or AIEOP-BFM 2017 standard of care protocol.
Biomarker or test result
A confirmed genetic change that switches on the JAK-STAT pathway (CRLF2, JAK2, EPOR, or CRLF2 on the surface of leukemia cells).

Main reasons for not taking part

  • ALL classed as standard or intermediate risk
  • Early high-risk ALL without these genetic changes or CRLF2 on leukemia cells
  • Taking part in another clinical trial (except approved supportive-care add-on trials)
  • Another condition or circumstance that significantly conflicts with the protocol treatment

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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

Where in Poland

  • Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W BialymstokuBialystok, PolandTaking people
  • Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W BydgoszczyBydgoszcz, PolandTaking people
  • Uniwersytecki Szpital Dzieciecy W KrakowieCracow, PolandTaking people
  • Uniwersyteckie Centrum KliniczneGdansk, PolandTaking people
  • Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Samodzielny Publiczny Szpital Kliniczny Nr 6 Slaskiego Uniwersytetu Medycznego W KatowicachKatowice, PolandTaking people
  • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w KielcachKielce, PolandTaking people
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W LodziLodz, PolandTaking people
  • Uniwersytecki Szpital Dziecięcy w LublinieLublin, PolandTaking people
  • Wojewodzki Specjalistyczny Szpital Dzieciecy Im. Prof. Dr Stanislawa Popowskiego W Olsztynie Sp. z o.o.Olsztyn, PolandTaking people
  • Szpital Kliniczny Im. Karola Jonschera Uniwersytetu Medycznego Im. Karola Marcinkowskiego W PoznaniuPoznan, PolandTaking people
  • Kliniczny Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej w RzeszowieRzeszów, PolandTaking people
  • Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W SzczecinieSzczecin, PolandTaking people
  • Samodzielny Publiczny Dzieciecy Szpital Kliniczny Im. Jozefa Polikarpa Brudzinskiego W WarszawieWarsaw, PolandTaking people
  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we WroclawiuWroclaw, PolandTaking people
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W KatowicachZabrze, PolandTaking people

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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.
Plain-language title
Tests ruxolitinib with chemotherapy in children with acute lymphoblastic leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
4 April 2025