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Trial record 1 of 1 for:    NCT04886206
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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 (ILDA)

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ClinicalTrials.gov Identifier: NCT04886206
Recruitment Status : Recruiting
First Posted : May 13, 2021
Last Update Posted : May 11, 2022
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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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 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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia (AML) Biological: DLI Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Continual Reassessment Method for MTD
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study Testing the 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
Actual Study Start Date : November 10, 2021
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

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Arms and Interventions
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Intervention Details:
  • Biological: DLI
    the patients will receive the injection of donor lymphocytes from haplo-identical donor (the son or daughter or possibly nephew or niece of the patient). No immunosuppressive drugs will be used. The HLI dose levels are 1) 1x107 CD3+/kg 2) 5x107 CD3+/kg 3) 7.5x107 CD3+/kg 4) 1x108 CD3+/kg.The CRM method (Continual Reassessment Method) was chosen to specify the dose of cells to be injected, each patient being assigned a dose that is believed to be associated with the target toxicity corresponding to the maximum tolerated dose (MTD). The dose-toxicity curve will be readjusted after assessing the toxicity of each patient.

Outcome Measures
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Primary Outcome Measures :
  1. number of DLT [ Time Frame: by day 14 ]

Secondary Outcome Measures :
  1. cumulative incidence of relapse [ Time Frame: 1 YEAR ]
  2. relapse-free survival [ Time Frame: 1 YEAR ]
  3. overall survival [ Time Frame: 1 YEAR ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04886206


Contacts
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Contact: Thierry Guillaume 02 40 08 49 45 thierry.guillaume@chu-nantes.fr

Locations
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France
CHU de Nantes Recruiting
Nantes, France, 44000
Contact: Thierry Guillaume    0240084945    thierry.guillaume@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Thierry Guillaume CHU de Nantes
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT04886206    
Other Study ID Numbers: RC20_0357
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: May 11, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid