Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Aplastic Anemia, Chronic Myeloid Leukemia, Hodgkin's Disease, Multiple Myeloma, Myelodysplastic Syndrome, Non Hodgkin's Lymphoma
Conditions
Brief summary
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.
Interventions
BIOLOGICALallogeneic 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
Sponsors
University Hospital Regensburg
Wuerzburg University Hospital
University Hospital, Essen
German Research Foundation
University of Erlangen-Nürnberg Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with EBV DNA copies/ml plasma higher than 50,000 | for 120 days after administration of study medication |
| Number of participants with signs of a post-transplant lymphoproliferative disorder (PTLD) | for 120 days after administration of study medication |
| Number of participants with adverse events (AEs), adverse reactions (ARs), serious adverse events (SAEs), serious adverse reactions (SARs) and suspected unexpected serious adverse reaction (SUSARs) | for 120 days after administration of study medication |
Secondary
| Measure | Time frame |
|---|---|
| Change of antigen-specific antibody concentration in serum/plasma between dose groups | 1 day before and up to 120 days after administration of study medication |
| Number of patients with >5,000 CMV DNA copies/ml plasma or with signs of organ infestation by CMV between dose groups. | up to 120 days after administration of study medication |
| Change of Cytomegalovirus (CMV) DNA copies/ml plasma between dose groups | 1 day before and up to 120 days after administration of study medication |
| Change in the frequency of antibody-producing cells between dose groups | before and 7 days after preponed single vaccination |
| Change of mean absolute number of B-lymphocytes, naïve B-lymphocytes and memory B-lymphocytes between dose groups. | 1 day before and up to 120 days after administration of study medication |
Countries
Germany
Contacts
Primary ContactJulia Winkler, MD
Backup ContactWolf Rösler, MD
Outcome results
None listed