CompletedPhase 1

Phase I of Infusion of Selected Donor NK Cells After Allogeneic Stem Cell Transplantation

France17 participantsStarted 2013-04

Plain-language 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 stimulating factor (G-CSF) mobilized peripheral blood stem cells and Reduced Intensity Conditioning (RIC), as a potential substitute to usual "Donor Lymphocyte Infusion" (DLI), that contain the whole range of immune effectors. The trial will include several progressive steps: dose escalation up to a level compatible with the cost-effectiveness potential of the device and clinical situation and recombinant interleukin-2 (r-IL2) activation of selected NK cells in vitro prior to re-infusion.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patient treated with allogeneic stem cell transplantation
✓. 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 criteria

✕. 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

What they're measuring

Occurence of grade 3-4 toxicity within 30 days of NK cells infusion

Timeframe: day 30

Trial details

NCT IDNCT01853358

SponsorInstitut Paoli-Calmettes

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03-15

View on ClinicalTrials.gov More Hematological Malignancy trials