CD56+CD3- NK Cells Following Allogeneic Stem Cell Transplantation

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01336478
First received: March 22, 2011
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

The investigators propose a nonrandomized, Phase I study to assess the safety of infusion of NK cells that will be selected from sibling donors and infused to patients with hematological malignancies early following allogeneic stem cell transplantation.


Condition Intervention Phase
Haematological Malignancies
Allogeneic Stem Cell Transplant
CD56+CD3- NK Cells
Procedure: Infusion of donor derived ex-vivo selected NK cells to patients after transplant
Procedure: Haematology / Blood chemistry sampling
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Toxicity of Escalating Doses of Adoptively Infused ex Vivo Selected CD56+CD3- NK Cells on Day 7 Following Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies.

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Safety and toxicity donor CD56+CD3- NK cells [ Time Frame: Day 28 post NK cell infusion ] [ Designated as safety issue: Yes ]
    To evaluate the safety and toxicity of escalating doses of ex vivo selected donor CD56+CD3- NK cells, adoptively infused on day 7 following sibling allogeneic stem cell transplantation in patients with hematological malignancies. We will specifically look for the proportion of patients who develop infusion related toxicity. Toxicity will be defined as per the Common Terminology Criteria for Adverse Events v3.0 (CTCAE).


Secondary Outcome Measures:
  • Donor neutrophil and platelet engraftment [ Time Frame: Day 28 post stem cell infusion ] [ Designated as safety issue: Yes ]
    Donor neutrophil engraftment (Neut > 0.5 x10^9/L) and platelet engraftment (Plt > 20 x10^9/L)

  • Rates of acute GVHD (grade 2-4) [ Time Frame: Day 100 post stem cell infusion ] [ Designated as safety issue: Yes ]
    Risk of acute GVHD

  • Relapse rate [ Time Frame: 1 year post stem cell infusion ] [ Designated as safety issue: Yes ]
    Relapse


Enrollment: 0
Study Start Date: April 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Infusion of donor derived ex-vivo selected NK cells to patients after transplant
    Infusion of donor derived ex-vivo selected NK cells to patients after transplant
    Procedure: Haematology / Blood chemistry sampling
    Haematology / Blood chemistry sampling, collection of blood for ancillary lab research
Detailed Description:

Allogeneic hematopoietic stem cell transplantation (HSCT) is a very effective treatment for a number of hematological malignancies but relapse remains a major problem, especially in patients with high risk disease. Natural killer (NK) cells are immune cells that recognize and kill virally infected cells and tumor cells. NK cells are identified by the expression of the CD56 surface antigen and the lack of CD3. Their ability to kill tumor cells makes them promising to evaluate as effector cells for immunotherapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients undergoing an allogeneic HSCT from a sibling donor, as treatment for a hematological malignancy. The conditioning regimen, and in particular whether ablative or non ablative, will not be considered in the criteria for recruitment
  2. Patient and donor Age >18 years
  3. Patients and donors must have signed an informed consent form
  4. The donor must be willing and capable of donating lymphocytes for NK selection using apheresis techniques
  5. Donor must be fit to undergo leukapheresis

Exclusion Criteria:

  1. Life expectancy < 3 months
  2. ECOG performance status 3 or 4
  3. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, life threatening cardiac arrhythmia
  4. Patients will not be eligible if they receive in vivo T depletion with ATG, ALG or campath-1H
  5. HIV-positive patients
  6. Psychiatric illness/social situations that would limit compliance with study requirements and ability to comprehend the investigational nature of the study and provide informed consent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01336478

Locations
United Kingdom
Hammersmith Hospital
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Katy Rezvani, MD Imperial College Healthcare NHS Trust
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01336478     History of Changes
Other Study ID Numbers: JROHH0203
Study First Received: March 22, 2011
Last Updated: March 22, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
NK
natural killer
immunotherapy
leukemia
hematological malignancies
stem cell transplantation
adoptive therapy

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on July 23, 2014