Vaccination with HA-1 peptide in patients showing minimal residual disease or mixed chimerism after allogeneic stem cell transplantation and donor lymphocyte infusion - HA-1 peptide vaccination after stem cell transplantation

eiden University Medical Center0 个研究点开始时间: 2007年11月1日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Patients with AML, myelodysplasia (MDS), ALL, CML in accelerated phase or blastic transformation, CLL, MM or aggressive lymphoma, who underwent allo SCT (both myeloablative and non-myeloablative) followed by DLI for persistent mixed chimerism or smoldering disease
•Patient and donor HLA-A2 positive, patient HA-1 positive, donor HA-1 negative.
•WHO performance status of 0, 1 or 2 (see appendix)
•No pregnancy, not breast feeding
•Willing to use of effective contraception during the course of this trial and for at least three months after the last injection.
•Life expectation of > 3 months
•No severe psychological disturbances
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•HIV positivity
•Graft versus host disease grade 3 or 4
•At eight weeks after DLI a HA-1 specific immune response (defined by >0.2% of total CD8+ cells) in first three patients
•Rapidly progressive disease needing cytoreductive treatment
•At eight weeks after DLI a HA-1 specific immune response (defined by >1.0% of total CD8+ cells) in patients 4-24 if no toxicity >grade II in first three patients
•Between six and eight weeks after DLI a doubling of percentage HA-1 specific CD8+ cells to a final percentage >0.2%
•Necessity of persistent treatment with high-dose corticosteroids (> 20 mg prednisone a day), chemotherapy or immunosuppressive drugs.

发起方

eiden University Medical Center