2023-503394-37-00RecruitingPhase 3
MAGIC AML - Multiarm, Multicenter, RAndomized, Molecularly-GuIded Controlled Trial of Personalized Treatment Strategy - of Acute Myeloid Leukemia
Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Nov 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 520 (estimated)
- First submitted
- 21 Dec 2023
- Start date
- 23 Oct 2024
- Lead sponsor
- Medical University Of Lodz
- Diseases
- Acute myeloid leukemia
- EU CT number
- 2023-503394-37-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 520
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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 adults with newly diagnosed acute myeloid leukemia who are fit enough for intensive chemotherapy.
- Age
- 18 years or older and under 66 years.
- Sex
- Women and men can join.
- Disease stage
- Acute myeloid leukemia diagnosed by the WHO 2016 criteria. General condition ECOG 2 or better and HCT-CI comorbidity score of 3 or lower.
- Biomarker or test result
- The trial has separate arms for CBF-AML, for AML with FLT3 gene mutations, and for other AML.
Main reasons for not taking part
- Acute promyelocytic leukemia
- Pregnancy or breastfeeding
- Other active cancer
- HIV infection or active hepatitis B or C infection
- Organ failure that rules out intensive chemotherapy
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Acute Promyelocytic Leukemia
- Pregnancy and breastfeeding
- Other not described above abnormalities that exclude the patient from the study based on the Investigator's assessment
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | Poland | Recruiting |
| Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza | Brzozów | Poland | Recruiting |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy | Bydgoszcz | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich | Chorzów | Poland | Recruiting |
| Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o. | Cracow | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie | Cracow | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | Recruiting |
| Szpitale Pomorskie Sp z o o | Gdynia | Poland | Recruiting |
| Samodzielny Publiczny Szpital Kliniczny Imienia Andrzeja Mieleckiego | Katowice | Poland | Recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Lodz | Poland | Recruiting |
| Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie | Lublin | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie | Olsztyn | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie | Szczecin | Poland | Recruiting |
| Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu | Torun | Poland | Recruiting |
| Instytut Hematologii I Transfuzjologii | Warsaw | Poland | Recruiting |
| Medical University of Warsaw | Warsaw | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.