- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01336478
CD56+CD3- NK Cells Following Allogeneic Stem Cell Transplantation
June 3, 2015 updated by: Imperial College London
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.
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.
Study Overview
Status
Withdrawn
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
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, W12 0HS
- Hammersmith Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- Patient and donor Age >18 years
- Patients and donors must have signed an informed consent form
- The donor must be willing and capable of donating lymphocytes for NK selection using apheresis techniques
- Donor must be fit to undergo leukapheresis
Exclusion Criteria:
- Life expectancy < 3 months
- ECOG performance status 3 or 4
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, life threatening cardiac arrhythmia
- Patients will not be eligible if they receive in vivo T depletion with ATG, ALG or campath-1H
- HIV-positive patients
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and toxicity donor CD56+CD3- NK cells
Time Frame: Day 28 post NK cell infusion
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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).
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Day 28 post NK cell infusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Donor neutrophil and platelet engraftment
Time Frame: Day 28 post stem cell infusion
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Donor neutrophil engraftment (Neut > 0.5 x10^9/L) and platelet engraftment (Plt > 20 x10^9/L)
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Day 28 post stem cell infusion
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Rates of acute GVHD (grade 2-4)
Time Frame: Day 100 post stem cell infusion
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Risk of acute GVHD
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Day 100 post stem cell infusion
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Relapse rate
Time Frame: 1 year post stem cell infusion
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Relapse
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1 year post stem cell infusion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (ANTICIPATED)
June 1, 2014
Study Completion (ANTICIPATED)
June 1, 2014
Study Registration Dates
First Submitted
March 22, 2011
First Submitted That Met QC Criteria
April 14, 2011
First Posted (ESTIMATE)
April 18, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
June 8, 2015
Last Update Submitted That Met QC Criteria
June 3, 2015
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JROHH0203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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