NCT01947322

Brief Summary

Leukemia cells can be killed by natural killer (NK) from HLA-I mismatched donor. The proposed study plans to realize an adoptive anti-leukaemic immunotherapy by infusion of HLA-I mismatched NK cells to treat poor prognosis acute myeloid leukemia patients. NK cells will be selected from HLA mismatch familial donor peripheral mononuclear cells by purification protocol. Before NK-infusion, patients received immunosuppressive chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2011

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

4.7 years

First QC Date

March 26, 2013

Last Update Submit

August 28, 2017

Conditions

Acute Myeloid Leukemia

Keywords

Natural killer cellHaploidenticalAcute myeloid leukemiaChemotherapy

Outcome Measures

Primary Outcomes (1)

  • duration of neutropenia inferior to 500 neutrophils /mm3

    from the day of NK infusion (day 0) up to 35 days

Study Arms (1)

Allogenic NK cells infusion

EXPERIMENTAL
Drug: Allogenic NK cells infusion

Interventions

Allogenic NK cells infusionDRUG

HLA Haploidentical selected NK cell infusion (one injection of 1x107/kg CD3-CD56+ cells) after chemotherapy associating fludarabine, cytosine arabinoside and cyclophosphamide.

Also known as: cellular therapy
Allogenic NK cells infusion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Secondary AML.
  • Previous autologous or allogeneic transplantation. Since the main objective of the study concerns the hematological toxicity, we decided to exclude patients with secondary AML or who had been previously transplanted because of their expected higher hematological toxicity.
  • Patient with allogeneic transplant project
  • HIV positive serology
  • Donor eligibility
  • HLA haploidentical brother, sister, child (older than 18 years), father, sister, cousin, uncle, aunt.
  • Donor with KIR ligand mismatch in the GvL direction
  • Absence of contraindication for leukapheresis.
  • Negative HIV1-2, HTLV-1-2, HBV, and HCV serology. Negative viral genomic screening for HTLV1-2 and HCV
  • Written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Service d'Hématologie Clinique du Pr. Leblond- Hôpital Pitié salpêtrière

Paris, 75013, France

Location

Service d'Hématologie adultes du Pr. Hermine - Hôpital Necker Enfants Malades

Paris, 75015, France

Location

Service d'Hématologie oncologie du Pr. Mohty -Hôpital Saint Antoine

Paris, 75571, France

Location

Service d'Hématologie Clinique du Pr. Cordonnier-Hôpital Henri Mondor

Paris, 94010, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Nathalie Dhedin, MD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2013

First Posted

September 20, 2013

Study Start

May 1, 2011

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

FR(4)