Status:
UNKNOWN
Safety Study of CD3/CD19 Depleted Haploidentical Stem Cells
Lead Sponsor:
University Children's Hospital Tuebingen
Conditions:
Acute Leukemias
Aplastic Anemia
Eligibility:
All Genders
1-25 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- \< 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01919866
Start Date
March 1 2004
End Date
December 1 2015
Last Update
October 8 2014
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
University Children's Hospital
Graz, Austria, 8036
2
University Children's Hospital
Halle, Germany, 6120
3
Medizinische Hochschule Zentrum für Kinderheilkunde
Hanover, Germany, 30625
4
University Children's Hospital
Jena, Germany, 7745