Last updated: May 5, 2022
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting
Phase
1
Condition
Leukemia (Pediatric)
Leukemia
Treatment
N/AClinical Study ID
NCT04886206
RC20_0357
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 mayreceive 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 chronicstable 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 thehematologist considers incompatible with intensive treatment
- ineligible for a classic allogeneic hematopoietic stem cell transplant due to thepresence of co-morbidities or too high a risk of toxicity >70 years old or at leastone of the following comorbidities: PS ≥ 2 or a history of heart failure requiringtreatment or LVEF ≤ 50% or chronic stable angina or FEV1 ≤ 65% or DLCO ≤ 65% orcreatinine 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
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 carryingout 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 familyauthorization
- Minor family donor (<18 years old)
Study Design
Total Participants: 12
Study Start date:
November 10, 2021
Estimated Completion Date:
November 30, 2024
Connect with a study center
CHU de Nantes
Nantes, 44000
FranceActive - Recruiting
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