Status:
UNKNOWN
Injection of Lymphocytes From Haplo-identical Donor Following Chemotherapy in Patients With High-risk Acute Myeloblastic Leukemia Not Eligible for an Allogeneic Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Nantes University Hospital
Conditions:
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Patients with high risk AML non eligible for an intensive treatment and for an allogeneic transplantation will be treated with azacitidine and venetoclax. The fourth, fifth and sixth injection of azac...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04886206
Start Date
November 10 2021
End Date
November 1 2024
Last Update
May 11 2022
Active Locations (1)
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1
CHU de Nantes
Nantes, France, 44000