A phase I trial of allogeneic tumour-activated natural killer lymphocytes for the treatment of selected patients with acute myeloid leukaemia.
| ISRCTN | ISRCTN11950134 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11950134 |
| EudraCT/CTIS number | 2005-006087-62 |
| Secondary identifying numbers | REC 7654 |
- Submission date
- 28/11/2014
- Registration date
- 17/12/2014
- Last edited
- 01/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Mark Lowdell
Scientific
Scientific
Dept of Haematology
Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom
 ORCID ID |
0000-0002-2600-5024 |
|---|
Study information
| Study design | Single-center non-randomised open-label phase I safety study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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. |
| Study acronym | TaNK in AML |
| Study objectives | Donor natural killer (NK) cells activated by tumour cells can be safely infused into a patient with acute myeloid leukaemia |
| Ethics approval(s) | UK National Patient Safety Agency National Research Ethics Service, 27/11/2007, ref. Royal Free Hospital LREC 7654 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/06/2007 |
| Completion date | 01/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 15 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 01/03/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Free Hospital
London
NW3 2QG
United Kingdom
NW3 2QG
United Kingdom
Sponsor information
University College London
University/education
University/education
Gower Street
London
WC1N
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Charity
Leukaemia Research Fund (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/06/2015 | Yes | No |
Editorial Notes
01/03/2019: Internal review.
