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

Last updated: May 5, 2022
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Leukemia (Pediatric)

Leukemia

Treatment

N/A

Clinical Study ID

NCT04886206
RC20_0357
  • Ages > 18
  • All Genders

Study 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 azacitidine will be followed by injection of haplo-identical lymphocytes (HLI). This is a single-center phase I study to identify the dose of HLI with the most tolerable toxicity. TheBayesian continuous reassessment method (CRM) will be used

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
    France

    Active - Recruiting

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