Natural Killer-cell Therapy for Acute Myeloid Leukemia

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Apr 14, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for adults with acute myeloid leukemia (AML) that has either come back after treatment (relapsed) or did not respond to previous therapies (refractory). The study is testing the use of natural killer (NK) cells, which are a type of immune cell that can help fight cancer. These NK cells are made in a lab and given to patients after a special type of chemotherapy that doesn't completely destroy the bone marrow. Some patients may also receive an additional support treatment called IL-2 to help boost the effect of the NK cells.

To participate in this trial, patients need to be at least 18 years old and have AML or similar conditions with stable disease. They should be in a situation where they cannot have a stem cell transplant at the moment and have a life expectancy of more than four months. Patients cannot currently have severe other health issues or active infections and must agree to be part of the study by signing a consent form. If eligible, participants will receive the NK cell treatment and be closely monitored for its effects. This trial offers hope for those who have limited treatment options available.

Gender

ALL

Eligibility 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)
• • Patients on concurrent chemotherapy or interferon-alpha treatment
• • Pregnancy or breastfeeding