Status:
COMPLETED
Haploidentical Transplantation With CD3/CD19 Depleted Grafts in Patients With Hematologic Malignancies
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to study the feasibility and Toxicity of allogeneic haploidentical hematopoietic cell transplantation with CD3/CD19 depleted stem cells and a dose reduced conditioning.
Detailed Description
Transplantation of a CD3/CD19 depleted stem cell grafts after dose reduced conditioning for the treatment of treatment refractory or relapsed hematologic malignancies after preceding allogeneic or aut...
Eligibility Criteria
Inclusion
- Age \<60, \>18 years
- 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
- \< 3 months after preceding HCT
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00202917
Start Date
February 1 2004
End Date
December 1 2010
Last Update
May 29 2014
Active Locations (7)
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1
University of Dresden Medical Center
Dresden, Germany, D-01307
2
Center for Marrow Transplantation
Essen, Germany, 45122
3
Medical Center University of Hamburg
Hamburg, Germany, 20246
4
Medical Center University of Muenster
Münster, Germany, 48129