A Phase II Study of Vemurafenib in Patients with Relapsed or Refractory Hairy Cell Leukemia

Protocol
12-200
Full Title
A Phase II Study of the BRAF Inhibitor, Vemurafenib, in Patients with Relapsed or Refractory Hairy Cell Leukemia
Purpose

The purpose of this study is to evaluate the safety and effectiveness of the drug vemurafenib in patients with hairy cell leukemia that persists or has returned despite prior therapy. Vemurafenib is approved for treating advanced melanoma, but its use in leukemia patients is considered investigational.

Vemurafenib works by targeting a mutated form of a protein called BRAF. Studies have shown that BRAF is altered in virtually all cases of hairy cell leukemia, so researchers want to see if vemurafenib is active against this cancer. Vemurafenib is a tablet that is taken orally (by mouth).

Investigator
Jae Park, MD
Jae Park - Physician Profile
Co-Investigators
Martin S. Tallman, MD -- Chief, Leukemia Service
Martin S. Tallman - Physician Profile
Eligibility

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

  • Patients must have hairy cell leukemia that persists or has returned despite prior therapy.
  • At least 6 weeks must have passed since completion of prior chemotherapy and entry into the study.
  • Patients may not have had prior treatment with MEK or BRAF inhibitors.
  • 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. Jae Park at 212-639-4048.

Disease(s)
Leukemia
Locations
ClinicalTrials.gov
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Clinical Trials

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