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A phase I trial of allogeneic tumour-activated natural killer lymphocytes for the treatment of selected patients with acute myeloid leukaemia.

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.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11950134
Enrollment
15
Registered
2014-12-17
Start date
2007-07-01
Completion date
Unknown
Last updated
2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with acute myeloid leukaemia Cancer Acute myeloid leukaemia

Interventions

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 irrad

Sponsors

University College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026