Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic 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.
Drug: fludarabine phosphate
Drug: mitoxantrone hydrochloride
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Consolidation With Campath-1H After FMC Induction in Patients With T-cell Chronic Lymphocytic Leukemia|
- Adverse effects at 2 months after treatment [ Designated as safety issue: Yes ]
- Remission rate at 2 months after treatment [ Designated as safety issue: No ]
- Overall survival at 2 months after treatment [ Designated as safety issue: No ]
- Progression-free survival at 2 months after treatment [ Designated as safety issue: No ]
- Remission quality at 2 months after treatment [ Designated as safety issue: No ]
|Study Start Date:||September 2002|
|Study Completion Date:||December 2009|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278213
|Allgemeines Krankenhaus - Universitatskliniken|
|Vienna, Austria, A-1090|
|Vienna, Austria, A-1140|
|Allgemeinen Krankenhaus Celle Kinderklinik|
|Celle, Germany, 29223|
|St. Johannes Hospital - Medical Klinik II|
|Duisburg, Germany, D-47166|
|Helios Klinikum Erfurt|
|Erfurt, Germany, D-99089|
|Essen, Germany, D-45147|
|Klinikum Garmisch - Partenkirchen GmbH|
|Garmisch-Partenkirchen, Germany, N 82467|
|Sana Klinikum Hof|
|Hof, Germany, 95032|
|University Hospital Schleswig-Holstein - Kiel Campus|
|Kiel, Germany, D-24116|
|Internistische Praxis - Ludwigsburg|
|Ludwigsburg, Germany, 71638|
|Sana Kliniken Luebeck|
|Luebeck, Germany, D-23560|
|Haematologische Praxis - Moenchengladbach|
|Moenchengladbach, Germany, 41239|
|Gemeinschaftliche Schwerpunktpraxis - Osnabrueck|
|Osnabrueck, Germany, 49074|
|Caritasklinik St. Theresia|
|Saarbrucken, Germany, D-66113|
|Schwerpunktpraxis fuer Haematologie und Onkologie|
|Saarbruecken, Germany, 66113|
|Southwest German Cancer Center at Eberhard-Karls-University|
|Tuebingen, Germany, D-72076|
|Wiesbaden, Germany, D-65199|
|Hamatologisch - Onkologische Praxis Wurzburg|
|Wurzburg, Germany, 97070|
|Klinikum des Landkreises Loebau-Zittau GmbH|
|Zittau, Germany, 02763|
|Study Chair:||Georg Hopfinger||Hanusch-Krankenhaus|