A Randomized, Multi-Center, Phase II Study of Vemurafenib Plus Obinutuzumab vs. Cladribine Plus Rituximab in Patients With Previously Untreated Hairy Cell Leukemia (HCL)

Summary

The researchers are doing this study to compare the safety of vemurafenib in combination with obinutuzumab to the standard of approach of cladribine in combination with rituximab. The researchers will look at which treatment causes fewer or milder side effects. Researchers think vemurafenib and obinutuzumab (non-chemotherapy drugs) may cause fewer side effects compared with the usual approach of chemotherapy drugs. They will also compare the two approaches to see which approach is more effective at eliminating cancer cells.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Vemurafenib

  Vemurafenib orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 days) for a total of 4 cycles.

• Drug
  Obinutuzumab

  Obinutuzumab will be administered concomitantly with vemurafenib starting at cycle 2 of treatment in cycles of 4 weeks.

• Drug
  Cladribine

  Cladribine IV on days 1-5 concurrently with rituximab.

• Drug
  Rituximab

  Rituximab on days 1-5 concurrently with rituximab.

Locations (10)