- Researchers are attempting to develop new treatments for hairy cell leukemia (HCL) that
has not responded well to or has recurred after standard HCL therapies. One nonstandard
treatment for HCL is rituximab, an antibody that binds to the cancer cells and helps the
immune system destroy them. By combining rituximab with other anti-cancer drugs,
researchers hope to determine whether the combined drugs are successful in treating HCL.
- Pentostatin and bendamustine are two anti-cancer drugs that have been used to treat
different kinds of blood and immune system cancers. Bendamustine is approved to treat
other kinds of leukemia and lymphoma, but it has not been used to treat HCL. Pentostatin
has been used for more than 20 years to treat HCL, but it has not been combined with
rituximab in official clinical trials.
- To determine whether rituximab with either pentostatin or bendamustine is a more
effective treatment for HCL than rituximab alone.
- To determine whether pentostatin or bendamustine is a more effective treatment for HCL
when combined with rituximab.
- Individuals at least 18 years of age who have been diagnosed with hairy cell leukemia that
has not responded well to or has relapsed after standard HCL therapies.
- The study will last for four treatment cycles of 28 days each.
- Prior to the study, participants will be screened with a full medical history and
physical exam, bone marrow biopsy (if one has not been performed in the last 6 months),
computed tomography (CT) or ultrasound scan, tumor measurements, and other tests as
required by the researchers. Participants will provide blood and urine samples at this
time as well.
- Rituximab with bendamustine: Participants will receive rituximab on Days 1 and 15 of
each cycle and bendamustine on Days 1 and 2 of each cycle, for a total of four cycles.
- Rituximab with pentostatin: Participants will receive rituximab on Days 1 and 15 of each
cycle and pentostatin on rituximab on Days 1 and 15 of each cycle, for a total of four
- Participants will have regular tests during the treatment cycles, including bone marrow
biopsies and CT or ultrasound scans. Participants will also provide regular blood and
urine samples to assess the results of treatment.