Administration of leukemia-reactive donor T cells after allogeneic stem cell transplantation or donor lymphocyte infusion to patients with persistent or relapsed mature B cell neoplasm with blood and/or bone marrow involvement - Leukemia-reactive donor T cells

eiden University Medical Center0 个研究点开始时间: 2012年9月24日最近更新: 2012年11月19日

研究概览

暂无简介。

•- allo-SCT patient with a sibling or unrelated stem cell donor matched for at least HLA-A, -B, -C, and –DR alleles (8/8).
•- Age 18-75 years.
•- WHO performance score 0-2.
•- Persistent or relapsed mature B cell neoplasm with blood and/or bone marrow involvement at least 3 months after allo-SCT or DLI.
•- Possibility to collect > 5 x 10^7 mononuclear cells containing > 25% malignant B cells from blood or bone marrow of patient, or availability of patient malignant B cells cryopreserved at a GMP-facility.
•- Donor willing to donate PBMC, or cryopreserved donor PBMC available in an amount of =1 x 10^9 MNC/ total.
•- Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- Life expectation < 3 months.
•- End stage irreversible multi-system organ failure.
•- Acute GvHD overall grade = II.
•- Treatment with corticosteroids in an equivalent dose of >0.5 mg/kg prednisone.
•- Pregnant or lactating women.
•- Severe psychological disturbances.

发起方

eiden University Medical Center