Condition category
Cancer
Date applied
28/11/2014
Date assigned
17/12/2014
Last edited
11/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Mark Lowdell

ORCID ID

http://orcid.org/0000-0002-2600-5024

Contact details

Dept of Haematology
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom

Additional identifiers

EudraCT number

2005-006087-62

ClinicalTrials.gov number

Protocol/serial number

REC 7654

Study information

Scientific title

A phase I trial of allogeneic tumour-activated natural killer lymphocytes after low dose TBI and fludarabine for the treatment of selected patients with acute myeloid leukaemia.

Acronym

TaNK in AML

Study hypothesis

Donor natural killer (NK) cells activated by tumour cells can be safely infused into a patient with acute myeloid leukaemia

Ethics approval

UK National Patient Safety Agency National Research Ethics Service, 27/11/2007, ref. Royal Free Hospital LREC 7654

Study design

Single-center non-randomised open-label phase I safety study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Patients with acute myeloid leukaemia

Intervention

A single skin biopsy will be taken at time of Hickman Line insertion from the surgical site. Each patient will receive five days of Fludarabine followed by one dose of single fraction total body irradiation. Monthly 20ml peripheral blood samples will be taken from day +30 until day + 180. Each patient will receive a single infusion of the IMP.

Intervention type

Biological/Vaccine

Phase

Drug names

Primary outcome measures

To determine the safety of infusion of allogeneic, tumour-activated NK cells after low dose radiotherapy plus medium dose chemotherapy with respect to acute / chronic GvHD and bone marrow suppression

Secondary outcome measures

1. To assess the quantitative and qualitative aspects of immune responses to acute myeloid leukaemia (AML) cells in these patients after NK cell infusion
2. To assess long term survival of donor NK cells in the peripheral circulation of recipients

Overall trial start date

01/06/2007

Overall trial end date

01/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

All recipients will have a diagnosis of acute myeloid leukaemia (AML) and be in one of the following subgroups:
1. Patients aged > 60 years in PR (blasts >5<20% in BM) after 2nd course of induction chemotherapy
2. Patients aged > 60 years with relapsed AML in CR2 after re-induction chemotherapy
3. Patients aged > 60 years in PR or CR after 2 courses of chemotherapy with poor risk disease using standard MRC criteria
4. Patients aged < 60 years beyond CR2 who are not suitable for stem cell transplantation with conventional or reduced intensity conditioning protocols

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15

Participant exclusion criteria

1. HIV 1-2 seropositive
2. Psychiatric, addictive, or any disorder which compromises ability to give true informed consent for participation in this study
3. Pregnant or lactating women
4. Patients whose life expectancy is severely limited by illness other than for which they are undergoing immunotherapy
5. Patients with other active malignancy
6. Patients with known physical or religious sensitivity or prior exposure to murine and/or ovine proteins

Recruitment start date

01/07/2007

Recruitment end date

01/03/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Free Hospital
London
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Gower Street
London
WC1N
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Leukaemia Research Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26062124

Publication citations

Additional files

Editorial Notes