In vivo measurement of lymphocyte kinetics during immune reconstitution after hematopoietic stem cell transplantation using [6,6-2H2]-glucose labeling - SILAS: Stable Isotope Labeling After Stemcelltransplantation

Academisch Medisch Centrum0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•Patients who underwent autologous or allogeneic stem cell transplantation because of a hematological malignancy
•Complete remission before HSCT
•Age 18-65 years
•WHO performance score 0-2
•Outpatient clinic patients
•Inclusion criteria - specific for autologous HSCT
•Indication for HSCT: relapsed non-Hodgkin*s lymphoma
•Remission-induction chemotherapy schedule including Rituximab
•Conditioning regimen: BEAM chemotherapy (BCNU (Carmustine), Ara-C (cytarabine), etoposide (VP16), Melphalan)
•Inclusion criteria - specific for allogeneic HSCT
•Indication for HSCT: acute myeloid leukemia (AML)
•Type of transplant: non-mismatched sibling donor (n=5) and matched unrelated donor (MUD; n=5), non-T cell depleted peripheral blood derived stem cell transplant
•Conditioning regimen (myeloablative): cyclophosphamide and total body irradiation for sibling donors; cyclophosphamide, total body irradiation and anti-thymocyte globulin for unrelated donors
•No or minimal immune suppression (prednisone <= 10 mg/day, no cyclosporine, no mycophenolate mofetil)
•No active graft versus host disease

•Acute graft-versus-host disease or infectious complications necessitating hospital admission;
•Active hematological malignancy;
•HIV, hepatitis B, hepatitis C infection
•Pre-treatment with immunomodulatory or lymphocyte depleting drugs such as lenalidomide, fludarabine or alemtuzumab
•AML relapse and/or previous autologous or allogeneic HSCT
•Significant renal, hepatic or cardiac dysfunction
•Diabetes mellitus type 1, DM type 2
•Alcohol and/or drug abuse
•Unwilling or not capable to use effective means of birthcontrol

发起方