Status:
TERMINATED
Allogeneic Stem Cell Transplantation in Pediatric Patients With Malignant and Non-malignant High-risk Diseases
Lead Sponsor:
Johann Wolfgang Goethe University Hospital
Conditions:
Malignant and Non-malignant High Risk Diseases
Eligibility:
All Genders
Up to 30 years
Phase:
PHASE2
Brief Summary
The aim of the study is to investigate the feasibility and toxicity of allogeneic haploidentical or unrelated transplantation with CD3/CD19 depleted stem cells associated with a reduced or a standard ...
Eligibility Criteria
Inclusion
- Patients aged 0 to 30 years
- Written informed consent from patient and/or parents or guardian
- Patients with Karnofsky Index \> 60%
- Malignant disease:
- acute lymphoblastic leukemia
- acute myeloid leukemia
- myelodysplastic syndrome
- chronic myeloid leukemia according to the standard indications
- solid tumors (e.g. neuroblastoma recurrence, soft-tissue sarcoma, Ewing's sarcoma, osteosarcoma, hepatoblastoma)
- . Non malignant disease:
- acquired anemias (e.g. severe aplastic anemia, particularly severe Evans syndrome)
- congenital anemias (e.g. thalassemia and sickle cell anemia)
- Women reliable contraception method when appropriate
Exclusion
- Participation in other clinical trials
- Patients, parents, or guardians unable to understand the nature, the importance and the implications of the procedure
- Pregnant or nursing women
- Patients who underwent a stem cell transplantation in the last 250 days
- Patients with kidney, heart or liver insufficiency
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00945126
Start Date
December 1 2006
End Date
August 1 2017
Last Update
August 15 2018
Active Locations (1)
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1
University Hospital Frankfurt, Dept. for Children and Adolescents, Division for Stem Cell Transplantation, Goethe University
Frankfurt am Main, Hesse, Germany, 60590