Status:
UNKNOWN
Haploidentical Transplantation With Early Adoptive Transfer of CD56+CD3- NK Cells
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
University of Leipzig
Conditions:
Acute Myeloid Leukemias
Advanced Hematological Malignancies
Eligibility:
All Genders
18-54 years
Phase:
PHASE1
PHASE2
Brief Summary
Experimental and clinical data suggest that alloreactive NK cells can reduce the risk of graft-rejection, GvHD and leukemic relapse after HLA-mismatched transplantation. The effectiveness of allogenei...
Eligibility Criteria
Inclusion
- Patients with AML or ALL in first CR with the following high risk features:
- AML with aberration Del (5q) -5, del (7q) -7, t(9;22) or t(6;9), abn 3q, 9q, 11q, 20q, 21q, 17p;
- AML with a complex caryotype;
- secondary AML after previous chemo- or radiotherapy or MDS;
- Ph-positive ALL
- Patients with AML or ALL after induction failure or in second CR
- Patients with CML in second chronic or accelerated phase
- Patients with malignant Lymphoma and the following high risk features:
- relapse after autologous transplantation
- primary chemotherapy refractory disease
- All patients must fulfill the following criteria:
- lack of a suitable HLA-identical family, unrelated or cord blood donor
- no active infection, no severe impairment of cardial, pulmonary, renal and hepatic function
- blast count in the marrow \< 30%
- informed consent
Exclusion
- active infection, no severe impairment of cardial, pulmonary, renal and hepatic function
- blast count in the marrow \> 30%
- unable or unwilling to sign and/or understand informed consent
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01220544
Start Date
July 1 2001
End Date
October 1 2011
Last Update
October 14 2010
Active Locations (2)
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1
Charite Campus Benjamin FRanklin, Medical Clinic III, Department of Hematology/Oncology
Berlin, State of Berlin, Germany, 12200
2
Medical Clinic II, Department of Hematology/Oncology, University of Leipzig
Leipzig, Germany, 04103