MAGIC AML - Multiarm, Multicenter, RAndomized, Molecularly-GuIded Controlled Trial of Personalized Treatment Strategy - of Acute Myeloid Leukemia
EU CTIS ID: 2023-503394-37-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Acute Myeloid Leukemia diagnosed according to the WHO 2016 criteria
- Age ≥ 18 and ≤65 years
- 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
You likely can't join if
- Acute Promyelocytic Leukemia
- Pregnancy and breastfeeding
- 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
See the full eligibility criteria
- Acute Myeloid Leukemia diagnosed according to the WHO 2016 criteria
- Age ≥ 18 and ≤65 years
- 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
- Acute Promyelocytic Leukemia
- Pregnancy and breastfeeding
- 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 not described above abnormalities that exclude the patient from the study based on the Investigator's assessment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.