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Phase I of Infusion of Selected Donor NK Cells After HLA Identical Allogeneic Stem Cell Transplantation Prepared With Reduced Intensity Conditioning - DLI-NK/IPC 2012-003

Phase 1
18 Years
70 Years
Open (Enrolling)
Hematological Malignancy

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Trial Information

Phase I of Infusion of Selected Donor NK Cells After HLA Identical Allogeneic Stem Cell Transplantation Prepared With Reduced Intensity Conditioning - DLI-NK/IPC 2012-003

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 (SCT), result in a high incidence of durable cytogenetic and molecular
remissions. However, regular documented effects are the occurrence of secondary aplasia
and/or graft-versus-host disease (GVHD) including the post RIC situation. These effects are
related to the high content of cytotoxic T cells in the DLI. Attempts to deplete CD8+
T-cells from DLI have been conducted with promising results but are not totally

More recently the infusion of r-IL2 ex-vivo activated autologous or allogeneic NK-selected
cells have been studied and the safety established in patients presenting various

Indeed, NK are thoroughly characterized in terms of genotype, phenotype and function.
Although a handful of clinical-grade reagents and devices exist that give access to the
human NK cell compartment, an immuno-selection device exists that allows for the selection
of NK cells from various types of hematopoietic cell collections in view of clinical
applications: the process produces CD3-/CD56+ cells in two steps and have been used in the
previous experiences.

Inclusion Criteria:

1. 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

2. Age above 18 and under 70

3. Eastern Cooperative Oncology Group (ECOG) 0-1 or Karnofsky index ≥ 70 %

4. Survival expectation > 6 months

5. Affiliation to social security

6. Signed informed consent from Donor and Patient

Exclusion Criteria:

1. Active grade >= 2 acute GVHD or corticotherapy ≥ 0.5 mg/kg/day at time of NK cell

2. Active infection

3. Psychiatric disorder occurring after transplant

4. Pregnant or breast-feeding women or without contraception

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

To establish the safety of donor NK cells infusion after HLA matched allogeneic transplant prepared by RIC.

Outcome Time Frame:

day 30

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Paoli-Calmettes


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

DLI-NK/IPC 2012-003



Start Date:

April 2013

Completion Date:

April 2016

Related Keywords:

  • Hematological Malignancy
  • hematological malignancy
  • stem cell transplantation
  • Neoplasms
  • Hematologic Neoplasms