Aldesleukin for Myelodysplastic syndrome with excess blasts | Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) | Acute myeloid leukemia

Inclusion criteria

• {"criterion_text":"-MDS with excess blasts, MDS/AML or AML or defined according to ELN 2022 (including MDS, MDS/AML or AML with mutated TP53); AML may be secondary to prior hematological disorders, including MDS, and/or therapy-related."}
• {"criterion_text":"- Stable or at least non-rapidly progressive disease with or without disease controlling medication."}
• {"criterion_text":"- Patients may belong to any of the following categories: o Relapsed/refractory disease after treatment with intensive chemotherapy, hypomethylating agents, targeted agents, autologous or allo-SCT (at least 6 months ago) and DLI o Newly diagnosed, untreated patients ineligible for allo-SCT"}
• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- WHO performance 0-2 (Appendix 2)"}
• {"criterion_text":"- Life expectancy of > 4 months"}
• {"criterion_text":"- Written informed consent"}
• {"criterion_text":"- Hydrea is allowed as pre-treatment to control blast count until day -3"}
• {"criterion_text":"- Hypomethylating agents decitabine or azacitidine are allowed until day -7 (i.e. last administration >28 days before start chemotherapy)."}

Exclusion criteria

• {"criterion_text":"- Rapid-progressive disease in case of previous therapy (see Appendix 1)."}
• {"criterion_text":"- Patients on immunosuppressive drugs or active GvHD"}
• {"criterion_text":"- Patients with active infections (viral, bacterial or fungal); acute anti-infectious therapy must have been completed within 7 days prior to study treatment"}
• {"criterion_text":"- Severe cardiovascular disease (CTCAE III-IV)"}
• {"criterion_text":"- Severe pulmonary dysfunction (CTCAE III-IV)"}
• {"criterion_text":"- Severe renal dysfunction (CTCAE III-IV)"}
• {"criterion_text":"- Severe hepatic dysfunction (CTCAE III-IV)"}
• {"criterion_text":"- Severe neurological or psychiatric dysfunction (CTCAE III-IV)"}
• {"criterion_text":"- Patients on concurrent chemotherapy or interferon-alpha treatment"}
• {"criterion_text":"- Pregnancy or breastfeeding"}

Primary endpoints

• {"endpoint_text":"-During the phase I safety study, patients will be evaluated intensively for toxicity caused by the RNK001 NK cell infusions, whether or not followed by SC IL-2, using the CTCAE toxicity criteria and graft versus host disease (GvHD) classification criteria, defining dose limiting toxicities (DLTs). For phase IIa of the study, clinical response to therapy is the main study parameter and will be defined according to European Leukemia Network (ELN) response criteria by day +28 post NK cell adminis.","definition_or_measurement_approach":"Phase I: evaluation using CTCAE toxicity criteria and graft versus host disease (GvHD) classification criteria to define dose limiting toxicities (DLTs). Phase IIa: clinical response defined according to European Leukemia Network (ELN) response criteria by day +28 post NK cell administration."}

Netherlands

Earliest CTIS Part Ii Submission Date

16-01-2025

Latest Decision Or Authorization Date

20-01-2025

Processing Time Days

4

Number Of Sites

1

Number Of Participants

16

Primary sponsor

Full Name

Stichting Radboud universitair medisch centrum

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"KWF Kankerbestrijding","duties_or_roles":"Source of monetary support","organisation_type":""}