Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Phase I Trial With Cohort Expansion of Pentostatin, Bendamustine and Ofatumumab (PBO) for the Treatment of Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma
This is a Phase 1 study with Cohort Expansion of Pentostatin, Bendamustine and Ofatumumab (PBO) for patients with previously treated Chronic Lymphocytic Leukemia (CLL) and B-cell Non-Hodgkin's Lymphoma (B- cell NHL). The purpose of this study is to determine the optimal dose of bendamustine in combination with pentostatin and ofatumumab, and then to see how safe these three drugs work together.
Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in the United States.
There has been considerable progress in understanding the biology and treatment of CLL in the
last 20 years. However, even with modern therapies, complete responses (CR) are achieved in
approximately 25% of the patients with relapsed/refractory disease. Multiple studies have
demonstrated that patients who achieve CR have better clinical outcomes than patients who do
not achieve a CR with therapy. B-cell NHL is composed of multiple subtypes of neoplasm. These
diseases are closely related to CLL in terms of natural history, biology, and responsiveness
to similar therapeutic agents. These diseases are not usually cured by available chemotherapy
and ultimately patients succumb to progression of resistant disease. Therefore, there is a
need to develop better therapies to improve survival in patients with CLL and B-cell NHL.
Preclinical and clinical data suggests that pentostatin, bendamustine, ofatumumab are active
drugs for the treatment of B-cell malignancies. In an earlier clinical trial conducted by Dr.
Weiss (lead site PI), the combination of pentostatin and cyclophosphamide had very good
activity in previously treated patients with B-cell neoplasms. This regimen was also better
tolerated than similar fludarabine-based regimen. The response rates were improved with
addition of rituximab, anti CD 20 antibody, to the above regimen. Studies have demonstrated
synergy between bendamustine and purine analogs like pentostatin in killing cancer cell types
of CLL and NHL. The combination of these three drugs (pentostatin, bendamustine and
ofatumumab) has not been tested in clinical setting and we anticipate that the combination
regimen will be more active than individual drugs alone. The aim of this trial is to find a
safe dose of bendamustine to be used in combination with pentostatin and ofatumumab in
patients with previously treated CLL and B-cell NHL.
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