drugset / Trial / NCT02890329

Ipilimumab and Decitabine in Treating Patients With Relapsed or Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia

NCT02890329 ↗

Phase 1 Active not recruiting 54 enrolled National Cancer Institute (NCI)
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of ipilimumab when given together with decitabine in treating patients with myelodysplastic syndrome or acute myeloid leukemia that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ipilimumab and decitabine may work better in treating patients with relapsed or refractory myelodysplastic syndrome or acute myeloid leukemia.

Timeline

Start
2017-09-05
Primary completion
2022-10-24
Completion
2026-08-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule — Intravenous
Subject Ipilimumab Monoclonal antibody 3 mg/kg Intravenous
Subject Ipilimumab Monoclonal antibody 5 mg/kg Intravenous
Subject Ipilimumab Monoclonal antibody 10 mg/kg Intravenous