A Phase I Study of BI 836858 in Patients with Relapsed or Refractory Acute Myeloid Leukemia

Protocol
12-133
Full Title
A Phase I, Open, Cohort Dose Escalation Trial with BI 836858 in Patients with Refractory or Relapsed Acute Myeloid Leukemia
Purpose

The purpose of this study is to find the highest dose of an investigational drug called BI 836858 that can be given safely in patients with acute myeloid leukemia (AML) that has returned or has stopped responding to prior therapies. BI 836858 is an antibody that works by targeting a protein on AML cells called CD33. Once the drug attaches to a cancer cell, it may start a process that kills the cancer cell. BI 836858 is given intravenously (by vein).

Investigator
Martin S. Tallman, MD -- Chief, Leukemia Service
Martin S. Tallman - Physician Profile
Co-Investigators
Dan Douer, MD -- Leader, Acute Lymphoblastic Leukemia Program
Dan Douer - Physician Profile
Eligibility

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

  • Patients must have AML that has returned or stopped responding to at least one prior regimen of chemotherapy.
  • At least 2 weeks must have passed since completion of prior treatment and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

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

Disease(s)
Leukemia
Leukemia: Acute Myelocytic Leukemia
Leukemia: Acute Myelogenous Leukemia
Locations
ClinicalTrials.gov
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