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
Phase
II
Disease Status
Relapsed/Refractory
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).

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
Related Diseases

Cancer Clinical Trials: Personalizing for Each Patient

Join our experts for a discussion of clinical trials on November 18. Clinical trials can give patients access to new drugs and other treatments before they are widely available, but how do you know if a trial is right for you?

Learn more »