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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Consolidation With Campath-1H After FMC Induction in Patients With T-cell Chronic Lymphocytic Leukemia

Conditions
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Prolymphocytic Leukemia

Intervention / Treatment
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* Biological: alemtuzumab
* Drug: cyclophosphamide
* Drug: fludarabine phosphate
* Drug: mitoxantrone hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: alemtuzumab|nan|
|Drug: cyclophosphamide|nan|
|Drug: fludarabine phosphate|nan|
|Drug: mitoxantrone hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects at 2 months after treatment |  |  | 
| Remission rate at 2 months after treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival at 2 months after treatment |  |  | 
| Progression-free survival at 2 months after treatment |  |  | 
| Remission quality at 2 months after treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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