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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01853358
• Date of registration: 04/04/2013
• Prospective Registration: No
• Primary sponsor: Institut Paoli-Calmettes
• Public title: Phase I of Infusion of Selected Donor NK Cells After Allogeneic Stem Cell Transplantation DLI-NK
• Scientific title: 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
• Date of first enrolment: April 2013
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01853358
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: BLAISE Didier, MD PhD
• Affiliation: Institut Paoli-Calmettes

Key inclusion & exclusion criteria

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
infusion

2. Active infection

3. Psychiatric disorder occurring after transplant

4. Pregnant or breast-feeding women or without contraception



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hematological Malignancy

Intervention(s)

Biological: NK Cell infusion

Primary Outcome(s)

Occurence of grade 3-4 toxicity within 30 days of NK cells infusion [Time Frame: day 30]

Secondary Outcome(s)

Number of infused cells population : CD3+, CD56+/CD16+, CD56-/CD16+, CD56+/CD16- (Determination) [Time Frame: baseline: at the time of the NK cells infusion]

number of NK cells function form baseline to Month 12 (kinetics) [Time Frame: at Day1, Day2, Day9, Day30, Month3, Month6, Month12]

relapse [Time Frame: up to one year after infusion]

Secondary ID(s)

DLI-NK/IPC 2012-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors