Prolymphocytic Leukemia
Conditions
Keywords
prolymphocytic leukemia, refractory chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, T-cell large granular lymphocyte leukemia
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALalemtuzumab
DRUGcyclophosphamide
DRUGfludarabine phosphate
DRUGmitoxantrone hydrochloride
Sponsors
German CLL Study Group
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse effects at 2 months after treatment | — |
| Remission rate at 2 months after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival at 2 months after treatment | — |
| Progression-free survival at 2 months after treatment | — |
| Remission quality at 2 months after treatment | — |
Countries
Austria, Germany
Outcome results
None listed