Status:
RECRUITING
Natural Killer-cell Therapy for Acute Myeloid Leukemia
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Acute Myeloid Leukemia Refractory
Acute Myeloid Leukemia, Relapsed, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
This study investigates an innovative treatment for relapsed or refractory acute myeloid leukemia (AML) exploiting administration of ex vivo-generated allogeneic natural killer (NK) cells with precedi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04347616
Start Date
December 3 2020
End Date
September 1 2025
Last Update
April 23 2024
Active Locations (1)
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1
Radboud University Medical Center
Nijmegen, Netherlands