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Feasibility and toxicity of haploidentical transplantation of CD3/CD19 depleted stem cells in combination with a toxicity reduced conditioning regimen or with standard conditioning regimens according to underlying disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transplantation of CD3/CD19 depleted stem cells | Experimental | Patients receive a minimum dosage of 10x10E6/kg bodyweight CD3/CD19 depleted CD34+ stem cells. Maximum dosage of residual T cells will be 1x10E5/kg BW |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transplantation of CD3/CD19 depleted stem cells | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment rate and transplant related mortality | engraftment rate will be evaluated by leukocyte counts in peripheral blood . Definition of engraftment: >500 neutrophiles/µl blood. Transplant related mortality will be evaluated at day 100 and day 365 post transplant | 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| Graft versus Host disease and speed of immune reconstitution | Incidence of acute and chronic GvHD will be evaluated according to Glucksberg criteria. Immune recovery will be evaluated by flow cytometry. Percentages and numbers of T, B and NK cells will be measured weekly until day 100, afterwards on day 180 and 365. | 365 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Lang, MD | Contact | +4970712981386 | peter.lang@med.uni-tuebingen.de | |
| Rupert Handgretinger, MD | Contact | +4970712984744 | rupert.handgretinger@med.uni-tuebingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Peter Lang, MD | University Children's Hospital Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children's Hospital | Recruiting | Graz | 8036 | Austria |
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| ID | Term |
|---|---|
| D000741 | Anemia, Aplastic |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000080983 | Bone Marrow Failure Disorders |
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| University Children's Hospital | Recruiting | Halle | 6120 | Germany |
|
| Medizinische Hochschule Zentrum für Kinderheilkunde | Recruiting | Hanover | 30625 | Germany |
|
| University Children's Hospital | Recruiting | Jena | 7745 | Germany |
|
| University Children's Hospital | Recruiting | Tübingen | 72076 | Germany |
|
| D001855 | Bone Marrow Diseases |