Full TitleA Phase 1 Dose Escalation and Expanded Cohort Study of EPZ-5676 in the Treatment of Pediatric Patients with Relapsed/Refractory Leukemias Bearing a Rearrangement of the MLL Gene Back to top
EPZ-5676 is an investigational drug that blocks a protein involved in leukemia growth called DOT1L. This protein is required for the growth of leukemias that contain an abnormal form of a gene called MLL. EPZ-5676 has shown promise against leukemia in laboratory studies and has also been evaluated in adult patients.
In this study, researchers want to find the highest dose of EPZ-5676 that can be given safely in children with acute leukemia that has come back or continued to grow despite prior treatment. EPZ-5676 is given via a continuous intravenous infusion over 28 days.Back to top
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- This study is for patients between the ages of 3 months and 18 years.
- Patients must have acute leukemia with an MLL mutation that has come back after therapy or has stopped responding to therapy.
- Patients must have recovered from the serious side effects of previous treatments before entering the study.