Prolymphocytic Leukemia Clinical Trial
Official title:
Consolidation With Campath-1H After FMC Induction in Patients With T-cell Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and
mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing
the cells or by stopping them from dividing. Giving more than one drug (combination
chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as alemtuzumab, can
block cancer growth in different ways. Some block the ability of cancer cells to grow and
spread. Others can find cancer cells and help kill them or carry cancer-killing substances to
them. Combination chemotherapy followed by alemtuzumab may be effective in treating chronic
lymphocytic leukemia and prolymphocytic leukemia.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy followed by
alemtuzumab works in treating patients with T-cell chronic lymphocytic leukemia or
prolymphocytic leukemia.
OBJECTIVES:
Primary
- Determine the number of severe adverse events and life-threatening infections in
patients with T-cell chronic lymphocytic leukemia or T-cell prolymphocytic leukemia
treated with induction chemotherapy comprising fludarabine, cyclophosphamide, and
mitoxantrone hydrochloride followed by consolidation therapy comprising alemtuzumab.
- Determine the remission rate in patients treated with this regimen.
Secondary
- Determine the overall and progression-free survival of patients treated with this
regimen.
- Determine the quality of remission in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising fludarabine IV and cyclophosphamide IV for
3 days and mitoxantrone hydrochloride IV on 1 day. Treatment repeats every 28 days for up to
4 courses. Patients then receive consolidation therapy comprising alemtuzumab IV 3 times in
week 1 and then weekly for up to 11 weeks.
PROJECTED ACCRUAL: A total of 17 patients will be accrued for this study.
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