Safety Study of CD3/CD19 Depleted Haploidentical Stem Cells
NCT ID: NCT01919866
Last Updated: 2014-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
120 participants
INTERVENTIONAL
2004-03-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Transplantation of CD3/CD19 depleted stem cells
Patients receive a minimum dosage of 10x10E6/kg bodyweight CD3/CD19 depleted CD34+ stem cells. Maximum dosage of residual T cells will be 1x10E5/kg BW
Transplantation of CD3/CD19 depleted stem cells
Interventions
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Transplantation of CD3/CD19 depleted stem cells
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
25 Years
ALL
No
Sponsors
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University Children's Hospital Tuebingen
OTHER
Responsible Party
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Peter Lang
Prof. Dr. med.
Principal Investigators
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Peter Lang, MD
Role: PRINCIPAL_INVESTIGATOR
University Children's Hospital Tuebingen
Locations
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University Children's Hospital
Graz, , Austria
University Children's Hospital
Halle, , Germany
Medizinische Hochschule Zentrum für Kinderheilkunde
Hanover, , Germany
University Children's Hospital
Jena, , Germany
University Children's Hospital
Tübingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1075/01 PEI
Identifier Type: -
Identifier Source: org_study_id
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