Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia

Официальное название

A Phase II, Multicenter, Open Label Study Evaluating the Efficacy and the Tolerance of Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia (MTSA)

Обзор

This study aims at evaluating the safety and the tolerance of the micro-transplantation in elderly patients with acute myeloid leukemia who are ineligible to conventional allogeneic transplantation.

Подробное описание

Acute Myeloid Leukemia (AML) is an aggressive hematological malignancy with a median age at diagnosis of 65 years. Outcomes of AML in elderly population remain unsatisfactory with low rates of complete remission, poor disease-free and overall survival. Therapeutic management of older patients with AML deals with patient-related features (i.e. comorbid conditions and performance status) as well as disease-related prognostic factors (i.e. cytogenetics and molecular genetics). Even if allogeneic hematopoietic-cell transplantation provides the strongest antineoplasic effect, this treatment option remains limited for older patients owing to toxicities, the development of significant graft-versus-host disease (GVHD) and logistics of donor availability. More recently, micro-transplantation has emerged as an alternative strategy based on the infusion of mobilized HLA-mismatched related donor cells after induction chemotherapy, thus exerting a graft-versus-leukemia effect without substantial donor engraftment and GVHD. Therefore, there is much of interest in investigating the efficacy and the safety of this method for older patients with AML who are not candidates for allogeneic stem cell transplantation.

Вмешательства

• Другое HLA-mismatched micro-transplantation after induction chemotherapy
  HLA-mismatched micro-transplantation after induction chemotherapy

Первичные конечные точки

• Rate of overall survival [Срок оценки: 2 years]

Вторичные конечные точки (8)

• Hematopoietic recovery [Срок оценки: 3 months]
• Hematopoietic recovery [Срок оценки: 3 months]
• Hematopoietic recovery [Срок оценки: 3 months]
• Rate of complete remission [Срок оценки: 2 years]
• GVHD (graft versus host disease) [Срок оценки: 2 years]
• Median overall survival [Срок оценки: 2 years]
• Median progression-free survival [Срок оценки: 2 years]
• Microchimerism [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Patient affiliated to a social security regimen or beneficiary of the same
• Signed written informed consent form
• Patient, ≥ 60 years-old - < 75 years-old, with established diagnosis of de novo or secondary AML with intermediate-risk or adverse-risk cytogenetic profile, or with established myelodysplasic syndromes (RAEB), in pathologically confirmed complete remission following anti-leukemic induction therapy (<5% blasts)
• Contra-indication to conditioning regimen in conventional allogeneic transplantation

Критерии исключения

• Patient with established diagnosis of acute myeloid leukemia with standard-risk cytogenetic profile
• Promyelocytic leukemia t(15;17)
• CBF-AML t(8;21) or inv(16)
• Normal karyotype with a favorable molecular profile: NPM1+ and FLT3-; NPM1+, FLT3- and double mutation CEBPα or chronic myeloid leukemia in blastic phase
• Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
• Refusing participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 7 центров

• CHU Estaing — Clermont-Ferrand
• Centre Hospitalier Universitaire de Grenoble — Grenoble
• CHRU de Lille — Lille
• Centre Hospitalier Lyon Sud — Lyon
• Centre Hospitalier Universitaire de Nancy — Nancy
• Hôpital de la Pitié-Salpêtrière — Paris
• CHU de Saint-Etienne — Saint-Etienne

Идентификаторы

NCT: NCT03439371 · 2017-1201 · 2017-A03572-51

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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