Open-label Clinical Trial to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates for Immune Reconstitution After Allogeneic Stem Cell Transplantation Measured as Response to a Antedated Single Vaccination

Prospective, Open-label, Multicentre Clinical Trial, Phase I/IIa, to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates CD3+-Depleted, CD19+-Enriched, Cryopreserved (Single Administration After Day 120 Following Allogeneic Stem Cell Transplantation (SCT), Donor-identical) in 4 Groups With Escalating Doses for Immune Response Enhancement, Measured as Response to a Antedated Single Vaccination

The reconstitution of a functioning immune system after allogeneic stem cell transplantation takes months to years. Particularly memory B-lymphocytes reconstitute poorly with the current conditioning regimes. During the period of intense immune suppression the patients are extremely susceptible to bacterial, fungal and, most importantly, viral infections.The adoptive transfer of B-lymphocytes from the stem-cell donor might significantly enhance humoral immunity for the patient. Aim of the study is to evaluate a new cellular therapy with B-lymphocytes regarding safety. A booster vaccination after B-lymphocyte transfer will evaluate the functionality of the transferred B-lymphocytes in the patient.

Inclusion Criteria:

1. patients after allogeneic stem cell transplantation
2. Serostatus for EBV: R-/D- oder R+/D- oder R+/D+

Exclusion Criteria:

1. Serostatus for EBV: R-/D+
2. Severe acute Graft versus Host Disease (GvHD) (Glucksberg grade III und IV)
3. Chronic GvHD in middle- or high-risk group according to NIH staging
4. Rituximab administration after SCT
5. >10.000 EBV DNA copies/ml plasma
6. Recurrence of the haematological disorder needing therapeutic intervention
7. Secondary transplantation
8. SCT with transplant from a haploidentical donor
9. SCT with transplant from umbilical cord blood
10. CD34+-enriched transplant
11. in vitro T-cell depleted transplant
12. Pregnant or breast-feeding female