Infusion of Cytokine Induced Killer (CIK) cells in patients relapsing after allogeneic stem cell transplantation - CIK

AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO (A.O. DI RILIEVO NAZIONALE)0 个研究点开始时间: 2008年11月5日最近更新: 2012年3月19日

试验速览

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•Patients with hematologic malignancies (excluding CML) with a hematologic or molecular relapse after allogeneic transplantation (at least 60 days should have elapsed since transplant). Immunosuppressive therapy should have been withdrawn or reduced to a minimum prior to CIK cells infusion. The original HLA-identical sibling or volunteer donor should be available, and willing and capable of donating lymphocytes Both patient and donor must give written informed consent according to local formats and appendix 1 Absence of serious intercurrent illness in both patient and donor Patients and donor must be negative for HBV, HCV and HIV. Negative pregnancy test of female patients and use of reliable contraceptive methods for patients of both genders.
•Are the trial subjects under 18? yes
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Absence of written informed consent Patients with active CMV disease Patients with acute GvHD > grade II Donor positive for HIV, HBV or HCV, or unfit to undergo leucapheresis A positive pregnancy test or reluctance to use reliable methods of contraception.

发起方

AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO (A.O. DI RILIEVO NAZIONALE)