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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.
 
ClinicalTrials.gov Identifier: NCT01336478
Recruitment Status : Withdrawn
First Posted : April 18, 2011
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Tracking Information
First Submitted Date  ICMJE March 22, 2011
First Posted Date  ICMJE April 18, 2011
Last Update Posted Date June 8, 2015
Study Start Date  ICMJE April 2011
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
  • 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)
  • Rates of acute GVHD (grade 2-4) [ Time Frame: Day 100 post stem cell infusion ]
    Risk of acute GVHD
  • Relapse rate [ Time Frame: 1 year post stem cell infusion ]
    Relapse
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CD56+CD3- NK Cells Following Allogeneic Stem Cell Transplantation
Official Title  ICMJE 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.
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Haematological Malignancies
  • Allogeneic Stem Cell Transplant
  • CD56+CD3- NK Cells
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 22, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2011)
24
Estimated Study Completion Date  ICMJE June 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01336478
Other Study ID Numbers  ICMJE JROHH0203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Katy Rezvani, MD Imperial College Healthcare NHS Trust
PRS Account Imperial College London
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP