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)

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) - Allogeneic NK-cell therapy in AML

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38045

Enrollment

Registered

2010-05-03

Start date

2011-10-12

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

Acute Myeloid Leukemia Blood cancer

Interventions

Allogeneic NK cell products generated ex vivo from CD34+ UCB cells will be transfused into patients in a single escalating dose up to 10x107 donor NK cells/kg body weight after completing standard c

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
The secondary study parameters are to evaluate the in vivo lifespan of the expanded NK cells following adoptive transfer and to determine the biological and clinical activity of NK cell infusion in study participants	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)