Immunotherapy with natural killer cells for acute myeloid leukemia

Phase 1

• Conditions: AML patients who do not have rapid progressive disease with or without disease controlling medication and who are not eligible for allogeneic SCT.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001929-27-NL
• Lead Sponsor: Radboud University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-17
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

MDS with excess blasts, MDS/AML or AML patients (de novo and secondary) according to ELN 2022 criteria, who have stable disease or non-rapidly progressive disease with or without disease controlling medication, who are not eligible for allogeneic SCT

- Age > 18 years
- WHO performance 0-2
- Life expectancy of > 4 months
- Written informed consent
- Hydrea is allowed as pre-treatment to control blast count until day -3
- Other disease controlling medication is allowed until day -7

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19

Exclusion Criteria

- Progressive disease in case of previous therapy
- Patients on immunosuppressive drugs or active GvHD
- Patients with active infections (viral, bacterial or fungal); acute anti-infectious therapy must have been completed within 7 days prior to study treatment
- Severe cardiovascular disease (CTCAE III-IV)
- Severe pulmonary dysfunction (CTCAE III-IV)
- Severe renal dysfunction (CTCAE III-IV)
- Severe hepatic dysfunction (CTCAE III-IV)
- Severe neurological or psychiatric dysfunction (CTCAE III-IV)
- Patients on concurrent chemotherapy or interferon-alpha treatment
- Pregnancy or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified