Natural Killer-cell Therapy for Acute Myeloid Leukemia

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study investigates an innovative treatment for relapsed or refractory acute myeloid leukemia exploiting administration of ex vivo-generated allogeneic natural killer (NK) cells with preceding non-myeloablative conditioning chemotherapy with or without subsequent in vivo IL-2 cytokine support.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: Dutch Cancer Society
• Treatments: Aldesleukin

Criteria

Inclusion Criteria:

• AML patients (de novo and secondary) or patients with MDS excess blasts-2 according to WHO criteria 2016, who have stable disease or non-rapidly progressive disease with or without disease controlling medication who are (at time of inclusion) ineligible for allo-SCT.

• Patients may belong to any of the following categories:

• Relapsed/refractory disease after treatment with intensive chemotherapy, hypomethylating agents, targeted agents, autologous or allo-SCT (at least 6 months ago) and DLI

• Newly diagnosed, untreated patients ineligible for allo-SCT

Other inclusion criteria:

• 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

Exclusion Criteria:

• Progressive disease according to ELN criteria 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 14 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)

• Presence of anti-HLA class I antibodies

• Patients on concurrent chemotherapy or interferon-alpha treatment

• Pregnancy or breastfeeding