Trials / Unknown
UnknownNCT02007811
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
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- University of Erlangen-Nürnberg Medical School · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Chronic Myeloid Leukemia
- Non Hodgkin's Lymphoma
- Hodgkin's Disease
- Myelodysplastic Syndrome
- Multiple Myeloma
- Aplastic Anemia
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2013-12-11
- Last updated
- 2014-03-26
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02007811. Inclusion in this directory is not an endorsement.