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

Phase 2UnknownNCT02007811

University of Erlangen-Nürnberg Medical School15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Chronic Myeloid Leukemia Non Hodgkin's Lymphoma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of participants with EBV DNA copies/ml plasma higher than 50,000

Time frame: for 120 days after administration of study medication

Number of participants with signs of a post-transplant lymphoproliferative disorder (PTLD)

Time frame: 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)

Time frame: for 120 days after administration of study medication

Secondary Outcomes

Change in the frequency of antibody-producing cells between dose groups

Time frame: 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.

Time frame: 1 day before and up to 120 days after administration of study medication

Change of antigen-specific antibody concentration in serum/plasma between dose groups

Time frame: 1 day before and up to 120 days after administration of study medication

Change of Cytomegalovirus (CMV) DNA copies/ml plasma between dose groups

Time frame: 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.

Time frame: up to 120 days after administration of study medication

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts