EUCTR2006-000393-76-DEActive, not recruitingPhase 1
Allogenic stem cell transplantation with CD3/CD19 depleted stem cells from haploidentical related and non-related donators in pediatric patients with and without malignant systemic diseases.
Johann Wolfgang Goethe-Universität Frankfurt am Main0 sites0 target enrollmentStarted: April 21, 2006Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patients age between 0 and 30 years
- •Written informed consent from the patient or from at least one of the patient’s parents (person having the care and custody of the child)
- •Patients with a Karnofsky Index > 60%
- •A malignant disease:
- •acute lymphatic leucemia
- •acute myeloic leucemia
- •myelodysplastic syndrome
- •chronic myeloic leucemia according to the standard indications
- •Solid Tumors (e.g. relapse of a neuroblastom, soft tissue sarcoma, Ewing sarcoma, osteo sarcoma, hepatoblastome
- •Or a non-malignant disease:
- •Acquired anemia (e.g. severe aplastic anemia, in particular the severe form of the Evans syndrome)
- •congenital anemia (e.g. thalassemia; sickle cell anemia)
- •A reliable contraception has to be observed in sexual reproductive women
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Patient or responsible person (person having the care and custody of the child), who is not able to understand the character and implications of this clinical trial
- •Pregant or breast-feeding women
- •Patients with a prior history of a stem cell transplantation within the last 250 days
- •Renal, cardiac or hepatic insufficiency
Investigators
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