Overview

Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia

Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
German CLL Study Group
Treatments:
Alemtuzumab
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Mitoxantrone
Criteria
DISEASE CHARACTERISTICS:

- Diagnosis of T-cell chronic lymphocytic leukemia (T-CLL) or T-cell prolymphocytic
leukemia (T-PLL)

- Previously untreated disease OR patient may have received up to 2 therapies

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy > 6 months

- No severe organ dysfunction

- No other concurrent or previous neoplasm

- No autoimmune hemolytic anemia or thrombocytopenia

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior fludarabine, mitoxantrone hydrochloride, cyclophosphamide, or alemtuzumab