A Phase II Study of Vemurafenib plus Obinutuzumab in Patients with Previously Untreated Classical Hairy Cell Leukemia

Full Title

MCT: A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients with Previously Untreated Classical Hairy Cell Leukemia

Purpose

Many patients relapse after standard chemotherapies initially given for hairy cell leukemia, and they may experience long-term side effects from these treatments. In this study, researchers are evaluating the safety and effectiveness of combining two medications, vemurafenib and obinutuzumab, in patients with previously untreated classical hairy cell leukemia. Both drugs are already used to treat other cancers; their use in this study is considered investigational.

Vemurafenib is a tablet that blocks an altered form of the BRAF protein, which is present in almost all patients with hairy cell leukemia. Obinutuzumab (which is given by vein) targets a protein called CD20, which is found on the surface of B cells, the white blood cells that are affected by hairy cell leukemia. When obinutuzumab attaches to CD20, it directly destroys the B cells and makes them more visible to the immune system, which then helps them attack and destroy cancerous B cells. In another study, adding a drug that targets CD20 to vemurafenib was more effective against hairy cell leukemia and lowered the chance of the cancer coming back.

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 has not been previously treated.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Jae Park at 212-639-4048.

Protocol

17-513

Phase

II

Investigator

Co-Investigators

Diseases