Decoy-Resistant Interleukin-18 (DR-18) for Relapse, Pre-emptive Treatment or Prophylaxis After Allogeneic Hematopoietic Cell Transplantation in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome (DR. DREAM)
Fred Hutchinson Cancer Center
Summary
This phase I trial tests the safety, side effects and best dose of decoy-resistant interleukin-18 (DR-18) and how well it works in treating patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has come back after a period of improvement (relapsed) or that remains despite treatment (persistent) after hematopoietic cell transplantation (HCT). HCT is the only curative therapy for most forms of AML and MDS. However, relapse occurs in a third of patients and is the most common cause of death after HCT. DR-18, a variant of the human cytokine interleukin-18, binds to IL-18 binding probein (IL-18BP) and overcomes the inhibitory effect of the IL-18BP on IL-18, which may boost the body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving DR-18 may be safe, tolerable and/or effective in treating patient with relapsed or persistent AML or MDS after HCT.
Description
OUTLINE: This is a dose-escalation study. INDUCTION: Patients receive DR-18 subcutaneously (SC) once weekly on approximately days 0, 7, 14, and 21. MAINTENANCE: After induction treatment, following a two-week pause (GROUP 1 - Treatment) or following discontinuation of prophylactic systemic immunosuppression post-transplant (GROUP 2 - Prophylaxis) patients without grade 3-4 acute GVHD, grade 2 acute GVHD requiring ongoing systemic immunosuppression, or moderate/severe chronic GVHD may receive DR-18 SC approximately for 4 additional weeks. Additionally, patients undergo blood and bone marrow…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No