A Phase I Study of EPZ-5676 in Patients with Relapsed/Refractory Leukemia and Other Advanced Hematologic Cancers

Protocol
12-181
Full Title
A Phase 1, Open-Label, Dose Escalation and Expanded Cohort, Continuous Intravenous Infusion, Multicenter Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EPZ-5676 in Treatment Relapsed/Refractory Patients with Leukemias Involving Translocations of the MLL Gene at 11q23 or Advanced Hematologic Malignancies
Phase
I
Purpose

EPZ-5676 is an investigational drug that blocks a protein involved in leukemia growth called DOT1L. It has shown promise against leukemia in laboratory studies.

In this study, researchers are evaluating the safety of EPZ-5676 in patients with leukemia that has returned or persists despite standard treatment and in patients with other advanced hematologic cancers. EPZ-5676 is given via a continuous intravenous infusion over 21 days.

Co-Investigators
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have leukemia that has returned or persisted despite at least one prior regimen of chemotherapy and contains a translocation (switching of genetic material) in the MLL gene. Patients with other types of hematologic cancers may also be eligible.
  • Patients may not be candidates for a stem cell transplant from a donor.
  • At least two weeks must have passed since completion of prior therapy and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Martin Tallman at 212-639-3842.

Disease(s)
Hematology: Hematologic Malignancies
Hematology: Myelodysplastic Syndrome
Leukemia
Leukemia: Acute Lymphoblastic Leukemia
Leukemia: Acute Myelocytic Leukemia
Leukemia: Acute Myelogenous Leukemia
Leukemia: Chronic Myelocytic Leukemia
Leukemia: Myelodysplastic Syndrome
Leukemia: Myeloproliferative Neoplasm
Locations