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CD56+CD3- NK Cells Following Allogeneic Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01336478
Recruitment Status : Withdrawn
First Posted : April 18, 2011
Last Update Posted : June 8, 2015
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
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 or disease Intervention/treatment 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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : April 2011
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

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

Primary Outcome Measures :
  1. Safety and toxicity donor CD56+CD3- NK cells [ Time Frame: Day 28 post NK cell infusion ]
    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 :
  1. Donor neutrophil and platelet engraftment [ Time Frame: Day 28 post stem cell infusion ]
    Donor neutrophil engraftment (Neut > 0.5 x10^9/L) and platelet engraftment (Plt > 20 x10^9/L)

  2. Rates of acute GVHD (grade 2-4) [ Time Frame: Day 100 post stem cell infusion ]
    Risk of acute GVHD

  3. Relapse rate [ Time Frame: 1 year post stem cell infusion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01336478

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United Kingdom
Hammersmith Hospital
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Imperial College London
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Principal Investigator: Katy Rezvani, MD Imperial College Healthcare NHS Trust
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Responsible Party: Imperial College London Identifier: NCT01336478    
Other Study ID Numbers: JROHH0203
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: March 2012
Keywords provided by Imperial College London:
natural killer
hematological malignancies
stem cell transplantation
adoptive therapy
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases