Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT04886206
Eligibility Criteria:
Inclusion Criteria:
* age ≥18 years
* patients with de novo or secondary AML, with an unfavorable or intermediate karyotype (according to the 2017 ELN classification), or patients with relapsing AML who may receive second-line treatment
* not candidates for intensive induction, for the following reasons
* 75 years or ≥ 18 to 74 years and at least one of the following comorbidities: PS ≥ 2 or a history of heart failure requiring treatment or LVEF ≤ 50% or chronic stable angina or FEV1 ≤ 65% or DLCO ≤ 65% or creatinine clearance \<45 ml / min; or liver damage with total bilirubin\> 1.5 N or other comorbidities that the hematologist considers incompatible with intensive treatment
* ineligible for a classic allogeneic hematopoietic stem cell transplant due to the presence of co-morbidities or too high a risk of toxicity \>70 years old or at least one of the following comorbidities: PS ≥ 2 or a history of heart failure requiring treatment or LVEF ≤ 50% or chronic stable angina or FEV1 ≤ 65% or DLCO ≤ 65% or creatinine clearance \<45 ml / min; or liver damage with total bilirubin\> 1.5 N
* may receive chemotherapy with hypomethylating agents have a partially compatible (haplo-identical) major family donor (≥18 years old) eligible for lymphocyte donation.
Exclusion Criteria:
* AML with favorable karyotype (according to ELN 2017) in RC1
* Patient with refractory or progressive AML
* Other progressive cancer in progress
* Karnosky index \<60% or PS\> 2
* Severe hepatic function disturbance: transaminases\> 5 N, hyperbilirubinemia\> 30 µm / L
* Severe infection requiring hospitalization.
* Psychiatric illness compromising the understanding of the information or the carrying out of the study.
* woman of childbearing potential and refusing an effective method of contraception.
* Minor
* Adult under tutorship or curatorship, under legal protection or under family authorization
* Minor family donor (\<18 years old)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04886206
Study Brief:
Protocol Section:
NCT04886206