Haploidentical Transplantation With CD3/CD19 Depleted Grafts in Patients With Hematologic Malignancies
NCT ID: NCT00202917
Last Updated: 2014-05-29
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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COMPLETED
PHASE1/PHASE2
61 participants
INTERVENTIONAL
2004-02-29
2010-12-31
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
Interventions
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Fludarabine
Thiotepa
Melphalan
OKT-3
CD3/CD19 depletion on CliniMACS
Eligibility Criteria
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Inclusion Criteria
* Karnofsky \>60%
* High risk hematologic malignancy or relapse after preceding auto/allo HCT in patients with:
* ALL
* AML
* PNH
* MDS (RAEB-t/secondary AML)
* NHL
* ALL
* HD
* CML
* MM
* No HLA-identical MRD or URD if not preceding allo-HCT
* Use haploidentical donor with KIR-Mismatch if choice
Exclusion Criteria
* Active cerebral seizures
* \> 30% blasts in BM if ALL/AML/CML-BC
* Completely chemo-refractory
* Preceding myocardial infarction
* Ejection fraction \<30 % echocardiography
* Creatinine clearance \<50 ml/min
* Respiratory insufficiency on supplemental O2 or DLCO \< 30%
* Allergy against murine antibodies
* HIV infection
* Pregnancy
* Unable for informed consent
18 Years
60 Years
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Principal Investigators
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Wolfgang A Bethge, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tuebingen Medical Center
Locations
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University of Dresden Medical Center
Dresden, , Germany
Center for Marrow Transplantation
Essen, , Germany
Medical Center University of Hamburg
Hamburg, , Germany
Medical Center University of Muenster
Münster, , Germany
South West German Cancer Center, University of Tuebingen Medical Center
Tübingen, , Germany
Deutsche Klinik für Diagnostik
Wiesbaden, , Germany
University of Wuerzburg Medical Center
Würzburg, , Germany
Countries
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References
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Federmann B, Bornhauser M, Meisner C, Kordelas L, Beelen DW, Stuhler G, Stelljes M, Schwerdtfeger R, Christopeit M, Behre G, Faul C, Vogel W, Schumm M, Handgretinger R, Kanz L, Bethge WA. Haploidentical allogeneic hematopoietic cell transplantation in adults using CD3/CD19 depletion and reduced intensity conditioning: a phase II study. Haematologica. 2012 Oct;97(10):1523-31. doi: 10.3324/haematol.2011.059378. Epub 2012 Apr 4.
Related Links
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Related Info
Other Identifiers
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IRB Project Nr. 21/2004
Identifier Type: -
Identifier Source: secondary_id
HSZ-001
Identifier Type: -
Identifier Source: secondary_id
E203/2004
Identifier Type: -
Identifier Source: org_study_id
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