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New treatment option for Acute Myeloid Leukemia
Official title IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.
ClinicalTrials.gov ID: NCT06713837
What this study is testing
What is High intensity therapies?
High intensity therapies is an investigational medicine, being studied as a potential treatment for acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, randomized, open-label, pragmatic low intervention clinical trial comparing high intensity reinduction chemotherapy with low intensity therapies in 1st or 2nd relapse Acute Myeloid Leukemia. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Non-Acute promyelocytic leukemia (APL) AML defined according World Health Organization (WHO) 2022 (or International Consensus Classification (ICC)...
- 1st or 2nd relapse or refractory according to European leukemia Network (ELN) 2022
- Patient is clinically candidate to both low intensity therapy and high dose chemotherapy in the opinion of the physician
- Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice
- No specific treatment protocol can be rationally considered better suited to patient needs.This specifically include, but is not limited to: i) the...
You likely can't join if
- Known contraindication to the study drug that will be selected by the treating physician within the list of high or low intensity treatment...
- Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to...
- Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment.
See the full eligibility criteria
- Non-Acute promyelocytic leukemia (APL) AML defined according World Health Organization (WHO) 2022 (or International Consensus Classification (ICC) 2022) criteria
- 1st or 2nd relapse or refractory according to European leukemia Network (ELN) 2022
- Patient is clinically candidate to both low intensity therapy and high dose chemotherapy in the opinion of the physician
- Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice
- No specific treatment protocol can be rationally considered better suited to patient needs.This specifically include, but is not limited to: i) the availability of a drug that is already demonstrated superior to...
- Male or Female, aged\>18 years
- Eastern Cooperative Oncology Group (ECOG) performance status \<4
- A female participant is eligible to participate if she is not pregnant and not breastfeeding. If Women of childbearing potential (WOCBP), negative serum pregnancy test within 14 days of starting treatment must be...
- Participant is willing and able to give informed consent for participation in the study
- Known contraindication to the study drug that will be selected by the treating physician within the list of high or low intensity treatment, according to most update version of Summary of Product Characteristics (SmPC)...
- Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to randomization
- Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Brno, Czechia
- Hradec Králové, Czechia
- Olomouc, Czechia
- Ostrava, Czechia
- Pilsen, Czechia
- Aachen, Germany
- Greifswald, Germany
- Halle, Germany
- Rostock, Germany
- Zwickau, Germany
- Bologna, BO, Italy
- Genova, GE, Italy
- Palermo, PA, Italy
- Pescara, PE, Italy
- Perugia, PG, Italy
- Ravenna, RA, Italy
- Roma, RM, Italy
- Torino, TO, Italy
- Ancona, Italy
- Brescia, Italy
+ 20 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brno, Czechia; Hradec Králové, Czechia; Olomouc, Czechia; Ostrava, Czechia; Pilsen, Czechia; Aachen, Germany and 34 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.