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

Phase 1

Completed

• Conditions: Patients with acute myeloid leukaemia; Cancer; Acute myeloid leukaemia

• Registration Number: ISRCTN11950134
• Lead Sponsor: niversity College London

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2011-03-01
• Study Start: 2014-12-17
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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