Aplastic Anemia Clinical Trial
Official title:
Haploidentical Stem Cell Transplantation With CD3/CD19 Depleted Stem Cells in Pediatric Patients With Refractory Hematological and Oncological Diseases
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 25 Years |
Eligibility |
Inclusion Criteria: - patients with primary refractory or relapsed disease (including relapse after previous SCT and active disease) - AML in complete remission of refractory - MDS RAEB-t/secondary AML - ALL - CML - Non-Hodgkin Lymphoma / Hodgkin Lymphoma - non malignant diseases (aplastic anemia, thalassemia, SCID) - relapsed Neuroblastoma - relapsed soft tissue sarcoma (Rhabdomyosarcoma, Ewing sarcoma, PNET - soft tissue sarcoma with primary bone metastases or bone marrow - in whom no matched donor was available, Exclusion Criteria: - < 6 months after previous HSCT - active cerebral seizure conditions - massive progression of leukemias or solid tumours before planned trp. - left ventricular ejection fraction <25% - creatinine clearance <40ml/min before conditioning - respiratory insufficiency with oxygen demand or DLCO <30% - Bilirubin >4mg/dl, GOT/GPT >400 - severe infection (HIV, Aspergillosis) - pregnancy |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | University Children's Hospital | Graz | |
Germany | University Children's Hospital | Halle | |
Germany | Medizinische Hochschule Zentrum für Kinderheilkunde | Hannover | |
Germany | University Children's Hospital | Jena | |
Germany | University Children's Hospital | Tuebingen |
Lead Sponsor | Collaborator |
---|---|
University Children’s Hospital Tuebingen |
Austria, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | 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 | Yes |
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