Clinical trial NCT02007811: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Chronic Myeloid Leukemia
Non Hodgkin's Lymphoma
Hodgkin's Disease
Myelodysplastic Syndrome
Multiple Myeloma
Aplastic Anemia
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: University Hospital Regensburg
name: Wuerzburg University Hospital
name: University Hospital, Essen
name: German Research Foundation
First posted: 2013-12-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with EBV DNA copies/ml plasma higher than 50,000
timeFrame: for 120 days after administration of study medication
measure: Number of participants with signs of a post-transplant lymphoproliferative disorder (PTLD)
timeFrame: for 120 days after administration of study medication
measure: 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)
timeFrame: for 120 days after administration of study medication
Secondary outcomes:
measure: Change in the frequency of antibody-producing cells between dose groups
timeFrame: before and 7 days after preponed single vaccination
measure: Change of mean absolute number of B-lymphocytes, naïve B-lymphocytes and memory B-lymphocytes between dose groups.
timeFrame: 1 day before and up to 120 days after administration of study medication
measure: Change of antigen-specific antibody concentration in serum/plasma between dose groups
timeFrame: 1 day before and up to 120 days after administration of study medication
measure: Change of Cytomegalovirus (CMV) DNA copies/ml plasma between dose groups
timeFrame: 1 day before and up to 120 days after administration of study medication
measure: Number of patients with >5,000 CMV DNA copies/ml plasma or with signs of organ infestation by CMV between dose groups.
timeFrame: up to 120 days after administration of study medication
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Medical Department 5, University Hospital Erlangen
Study officials:
affiliation: University Hospital Erlangen
name: Julia Winkler, MD
role: PRINCIPAL_INVESTIGATOR
References: