Status:
COMPLETED
Phase I of Infusion of Selected Donor NK Cells After Allogeneic Stem Cell Transplantation
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Hematological Malignancy
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The goal of our study will be to determine the clinical and biological safety of infusing immuno-selected NK (Natural Killer) CD3-/CD56+ cells, early after allogeneic transplantation with colony stimu...
Detailed Description
In the mid 90's, it has been shown that donor lymphocyte infusions (DLI), when given for Chronic Myelocytic Leukemia (CML) that has relapsed after conventional allogeneic stem cell transplantation (SC...
Eligibility Criteria
Inclusion
- Patient treated with allogeneic stem cell transplantation
- Presenting an hematological malignancy with an intermediate, high or very high risk index according to the disease risk index developed by the Dana Farber Cancer Institute
- Donor: HLA matched related or unrelated (10/10) donor
- Graft: Peripheral stem cell transplant
- Reduced Intensity Conditioning as used in the current transplant program: Fludarabine, IV Busulfan and Thymoglobuline
- Age above 18 and under 70
- Eastern Cooperative Oncology Group (ECOG) 0-1 or Karnofsky index ≥ 70 %
- Survival expectation \> 6 months
- Affiliation to social security
- Signed informed consent from Donor and Patient
Exclusion
- Active grade \>= 2 acute GVHD or corticotherapy ≥ 0.5 mg/kg/day at time of NK cell infusion
- Active infection
- Psychiatric disorder occurring after transplant
- Pregnant or breast-feeding women or without contraception
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2018
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01853358
Start Date
April 1 2013
End Date
March 15 2018
Last Update
July 12 2018
Active Locations (1)
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1
Institut Paoli-Calmettes
Marseille, France, 13009