Prophylactic infusion of CD4 positive donor lymphocytes early after T-cell depleted allogeneic stem cell transplantation in patients with an unrelated donor - CD4+ donor lymphocytes

eiden University Medical Center0 个研究点开始时间: 2012年6月15日最近更新: 2012年10月2日

试验速览

暂无简介。

•Age > 18 years
•Patients with AML, myelodysplasia , ALL, CML in accelerated phase or blastic transformation, CLL, MM or (non) Hodgkin lymphoma, who are definitely planned to undergo an allo-SCT with an unrelated donor who is matched for HLA-A, B, C, DR and DQ.
•Life expectation of > 3 months
•WHO performance status of 0, 1 or 2
•Written informed consent according to the rules and regulations of the Leiden University Medical Center.
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Use of systemic immunosuppressive treatment (due to GVHD)
•Acute GVHD of the skin > grade 2 or progressive acute GVHD
•Progressive disease needing cytoreductive treatment
•Any concomitant disease preventing the safe administration of donor lymphocytes
•Severe psychological disturbances
•Severely limited life expectation due to diseases other than the malignancy
•Very high risk disease preceding allo-SCT for which already unselected DLI is planned to be given 3 months after allo-SCT.

发起方

eiden University Medical Center