Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation

Обзор

The study concerns donors and patients receiving allogeneic stem cell haematopoietic transplantation. The aim of the study is to analyse HSC graft content in immune effector T (naive, memory, activated, exhausted) and immunoregulatory cell subtypes (Tregs, iNKT, MDSC) and correlate the results with post-transplant immune reconstitution of those different cell subtypes and clinical events (graft-versus-host-disease, relapse, infections). An ancillary study will focus on the impact of microbiota dysbiosis on post-transplant immune response and regulatory cell subsets.

Вмешательства

• Биопрепарат Blood Sample
  Additional blood sample before graft, D0, D7, D15, D21, D30, D60, D90, D180, Y1, Y2
• Биопрепарат Bone marrow aspiration
  Additional bone marrow aspiration before graft, D30, D90, Y1
• Биопрепарат Blood sample
  Before donation
• Биопрепарат Allogeneic hematopoietic stem cell sample
  Allogeneic hematopoietic stem cell sample

Первичные конечные точки

• Proportions of regulatory immune cells in peripheral blood. [Срок оценки: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years]

Вторичные конечные точки (5)

• Occurrence of graft versus host (GVH) reaction after allografting of CSH [Срок оценки: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years]
• Incidence of relapse [Срок оценки: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years]
• Incidence of infections [Срок оценки: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years]
• Progress-free survival [Срок оценки: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years]
• Overall survival [Срок оценки: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years]

Критерии участия

Критерии включения

• patient of the Nancy CHRU, for whom a CSH allograft is planned. or
• hematopoietic stem cell donors received at Nancy's CHRU for the duration of the research

Критерии исключения

• Positive HIV
• active hepatitis B or C infection

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• CHRU de Nancy — Vandœuvre-lès-Nancy

Публикации

• Notarantonio AB, Morisset S, Piucco R, Peres M, Boulange L, Alitcher A, Brouard J, Monchablon L, Campidelli A, El Ouahabi S, Guisnel C, Moulin C, Kicki C, Roth-Guepin G, Feugier P, Bittencourt MC, Aarnink A, D'Aveni-Piney M, Hergalant S, Pagliuca S, Rubio MT. Differential Clinical and Immunological Impacts of Anti-T-Lymphocyte Globulin (ATLG) vs. Anti-Thymocyte Globulin (ATG) in Preventing Graft-V PMID 39905816
• Notarantonio AB, Bertrand A, Piucco R, Fievet G, Sartelet H, Boulange L, de Isla N, De Carvalho Bittencourt M, Hergalant S, Rubio MT, D'Aveni M. Highly immunosuppressive myeloid cells correlate with early relapse after allogeneic stem cell transplantation. Exp Hematol Oncol. 2024 May 11;13(1):50. doi: 10.1186/s40164-024-00516-4. PMID 38734654

Идентификаторы

NCT: NCT03357172 · 2018-A03267-48

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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