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

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Acute Myeloid LeukemiaAcute Lymphoblastic LeukemiaChronic Myeloid LeukemiaNon Hodgkin's LymphomaHodgkin's DiseaseMyelodysplastic SyndromeMultiple MyelomaAplastic Anemia
Interventions
BIOLOGICAL

allogeneic donor derived B-lymphocytes

CD3+-depleted, CD19+-enriched, cryopreserved (single administration after day 120 following allogeneic stem cell transplantation, donor-identical) in 4 groups with escalating doses

Trial Locations (1)

91054

RECRUITING

Medical Department 5, University Hospital Erlangen, Erlangen

Sponsors
All Listed Sponsors
collaborator

University Hospital Regensburg

OTHER

collaborator

Wuerzburg University Hospital

OTHER

collaborator

University Hospital, Essen

OTHER

collaborator

German Research Foundation

OTHER

lead

University of Erlangen-Nürnberg Medical School

OTHER