Allogeneic Stem Cell Transplantation in Pediatric Patients With Malignant and Non-malignant High-risk Diseases
NCT00945126 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2018-08-15
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 conditioning regimen in pediatric patients with malignant and non-malignant high-risk diseases, for whom allogeneic stem cell transplantation represents the only possible therapy option and no human leukocyte antigen (HLA) compatible related donors are available.
Conditions
- Malignant and Non-malignant High Risk Diseases
Interventions
- OTHER
-
Hematopoietic stem cell product from haploidentical or unrelated donor CD3/CD19 depleted with CliniMACS
The aim is to transplant 7x106 CD34+/kg of recipient body weight.
Sponsors & Collaborators
-
Johann Wolfgang Goethe University Hospital
lead OTHER
Principal Investigators
-
Peter Bader, Professor · University Hospital Frankfurt, Dept. for Children and Adolescents, Division for Stem Cell Transplantation, Goethe University.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-12-31
- Primary Completion
- 2017-08-31
- Completion
- 2017-08-31
Countries
- Germany
Study Locations
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