MAGIC AML - Multiarm, Multicenter, RAndomized, Molecularly-GuIded Controlled Trial of Personalized Treatment Strategy - of Acute Myeloid Leukemia
Key facts
- Where
- Bialystok, Brzozów, Bydgoszcz, Chorzów, Cracow, Gdansk, Gdynia, Katowice, Lodz, Lublin, Olsztyn, Poznan, Szczecin, Torun, Warsaw és Wroclaw, LengyelországSee the 18 sites
- Phase
- 3. fázis
Where in Lengyelország
- Uniwersytecki Szpital Kliniczny w BialymstokuBialystok, LengyelországTaking people
- Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.MarkiewiczaBrzozów, LengyelországTaking people
- Szpital Uniwersytecki nr 2 im dr Jana Biziela w BydgoszczyBydgoszcz, LengyelországTaking people
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali MiejskichChorzów, LengyelországTaking people
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracow, LengyelországTaking people
- Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.Cracow, LengyelországTaking people
- Uniwersyteckie Centrum KliniczneGdansk, LengyelországTaking people
- Szpitale Pomorskie Sp z o oGdynia, LengyelországTaking people
- Samodzielny Publiczny Szpital Kliniczny Imienia Andrzeja MieleckiegoKatowice, LengyelországTaking people
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w LodziLodz, LengyelországTaking people
- Samodzielny Publiczny Szpital Kliniczny nr 1 w LublinieLublin, LengyelországTaking people
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W OlsztynieOlsztyn, LengyelországTaking people
- Uniwersytecki Szpital Kliniczny w PoznaniuPoznan, LengyelországTaking people
- Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W SzczecinieSzczecin, LengyelországTaking people
- Wojewodzki Szpital Zespolony im. L. Rydygiera w ToruniuTorun, LengyelországTaking people
- Instytut Hematologii I TransfuzjologiiWarsaw, LengyelországTaking people
- Medical University of WarsawWarsaw, LengyelországTaking people
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we WroclawiuWroclaw, LengyelországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University Of Lodz
- Trial code
- EU 2023-503394-37-00
- Record updated
- 2026. november 4.
- Original description
Comparison of efficacy (measured as event-free survival; EFS) of induction treatment including:Read full original descriptionShow less
Comparison of efficacy (measured as event-free survival; EFS) of induction treatment including:
(i) cladribine in combination with daunorubicin, cytosine arabinoside and gemtuzumab ozogamicin (DAC+GO protocol) in CBF-AML patients compared to induction therapy according to DAC protocol;
(ii) cladribine in combination with daunorubicin, cytosine arabinoside and midostaurin (DAC+M protocol) in AML patients with FLT3 gene mutations compared to induction treatment according to the DA+M protocol;
(iii) venetoclax in combination with cladribine, daunorubicin and cytosine arabinoside (DAC+Ven protocol) compared to DAC protocol plus placebo in other AML patients
Inclusion: Acute Myeloid Leukemia diagnosed according to the WHO 2016 criteria; Age ≥ 18 and <66 years on the date of signing the informed consent form to participate in the study; General condition according to the ECOG scale ≤ 2; HCT-CI comorbidity index score ≤ 3; Informed, written consent to participate in the study; Consent to the use of effective contraception during the study with the use of contraception in both women and men; Negative serum or urine pregnancy test in women of childbearing age.
Exclusion: Other active cancer disease; HIV infection; Active infection with hepatitis B or C virus; Organ failure which is a contraindication to the use of intensive chemotherapy; Known hypersensitivity to any of the preparations used in the treatment; Acute Promyelocytic Leukemia; Pregnancy and breastfeeding; Other not described above abnormalities that exclude the patient from the study based on the Investigator's assessment.