Recurrent Small Lymphocytic Lymphoma Clinical Trial
Official title:
A Phase I Trial of Bendamustine Plus Alemtuzumab for the Treatment of Fludarabine Refractory Chronic Lymphocytic Leukemia
This phase I trial is studying the side effects and best dose of alemtuzumab when given together with bendamustine hydrochloride in treating patients with relapsed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that did not respond to fludarabine phosphate. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as alemtuzumab, can also block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bendamustine hydrochloride together with alemtuzumab may kill more cancer cells.
PRIMARY OBJECTIVES:
I. Evaluate the safety of the combination of alemtuzumab and bendamustine (bendamustine
hydrochloride) in patients with advanced CLL.
II. Establish the maximum tolerated dose of alemtuzumab up to the standard dose of 30mg
thrice weekly when combined with bendamustine at a standard dose of 70 mg/m^2 day 8 and 9
monthly.
III. Define a recommended dose for subsequent Phase II studies. IV. Evaluate preliminary
evidence of activity as determined by response rates with correlation to EAS flow cytometry.
OUTLINE: This is a dose-escalation study of alemtuzumab.
Patients receive bendamustine hydrochloride intravenously (IV) over 30-60 minutes on days 8
and 9 for up to 6 courses in the absence of disease progression or unacceptable toxicity and
alemtuzumab subcutaneously (SC) on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26.
After completion of study treatment, patients are followed every 3 months for 1 year.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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