Expanded Access Program (EAP) for Galinpepimut-S (GPS) in Patients Diagnosed With AML or MDS
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorSellas Life Sciences Group
About this trial
Single patient expanded access program to provide galinpepimut-S for eligible patients with AML or MDS who have no other treatment option.
Eligibility criteria
Qualifiers
Diagnosed with AML or MDS, as assessed by their Treating Physician;
Have no appropriate, comparable, or satisfactory alternative treatment available, or such alternatives have been tried without clinical success, including clinical studies;
Inability to participate in a GPS clinical study for the disease or conditions; and
Have a treating physician who has appropriately evaluated the benefit/risk profile for potential GPS treatment.
Disqualifiers
Prior clinically significant allergic reaction to Montanide, sargramostim (GM-CSF) or filgrastim (granulocyte colony stimulating factor [G-CSF]).
Patients with acute promyelocytic leukemia (APL) or any morphologic and molecular variants, inclusive.
Patients with a serious concurrent illness that in the opinion of the Treating Physician would pose an undue risk to the patient.
Patients who currently have central nervous system leukemia.
Trial design
Treatments tested in this trial
- Galinpepimut-S
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov