Infusion of ex vivo-cultured allogeneic NK cells in acute myeloid leukemia patients not eligible for stem cell transplantation (a phase I dose escalation study)

Completed

Conditions: Blood cancer
10024324
Acute Myeloid Leukemia

Registration Number: NL-OMON38045

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

* AML patients * 55 year of age
* Absence of anti-HLA antibodies
* CR after first line standard chemotherapy
* CR after second line chemotherapy
* WHO performance 0-1 (see appendix 3)
* Life expectancy > 6 months

Exclusion Criteria

- Patients candidates for SCT
- Progressive disease, no change or only minor response following induction and consolidation therapy
- Patients on immunosuppressive drugs
- Patients with active infections (viral, bacterial or fungal) that requires specific therapy. Acute anti-infectious therapy must have been completed within 14 days prior to study treatment
- Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease (appendix 2)
- Severe pulmonary dysfunction (CTCAE III-IV) (appendix 2)
- Severe renal dysfunction (serum creatinine > 3 times normal level) (appendix 2)
- Severe hepatic dysfunction (serum bilirubin or transaminases > 3 times normal level) (appendix 2)
- Presence of anti-HLA antibodies

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameters are to evaluate the safety and dose-limiting<br /><br>toxicity of allogeneic NK cell infusions with an escalating dose up to<br /><br>10x107/kg body weight ex vivo-expanded NK cells following immunosuppressive<br /><br>conditioning therapy in patients with AML not eligible for stem cell<br /><br>transplantation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are to evaluate the in vivo lifespan of the<br /><br>expanded NK cells following adoptive transfer and to determine the biological<br /><br>and clinical activity of NK cell infusion in study participants</p><br>