Combination Chemotherapy Followed By Alemtuzumab in Treating Patients With Chronic Lymphocytic Leukemia or Prolymphocytic Leukemia
- Conditions
- Prolymphocytic Leukemia
- Registration Number
- NCT00278213
- Lead Sponsor
- German CLL Study Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse effects at 2 months after treatment Remission rate at 2 months after treatment
- Secondary Outcome Measures
Name Time Method Overall survival at 2 months after treatment Progression-free survival at 2 months after treatment Remission quality at 2 months after treatment
Trial Locations
- Locations (19)
Allgemeines Krankenhaus - Universitatskliniken
🇦🇹Vienna, Austria
Hanuschkrankenhaus
🇦🇹Vienna, Austria
Allgemeinen Krankenhaus Celle Kinderklinik
🇩🇪Celle, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Klinikum Garmisch - Partenkirchen GmbH
🇩🇪Garmisch-Partenkirchen, Germany
Hamatologisch - Onkologische Praxis Wurzburg
🇩🇪Wurzburg, Germany
Helios Klinikum Erfurt
🇩🇪Erfurt, Germany
University Hospital Schleswig-Holstein - Kiel Campus
🇩🇪Kiel, Germany
Internistische Praxis - Ludwigsburg
🇩🇪Ludwigsburg, Germany
Gemeinschaftliche Schwerpunktpraxis - Osnabrueck
🇩🇪Osnabrueck, Germany
Sana Kliniken Luebeck
🇩🇪Luebeck, Germany
Dr. Horst-Schmidt-Kliniken
🇩🇪Wiesbaden, Germany
Caritasklinik St. Theresia
🇩🇪Saarbrucken, Germany
Sana Klinikum Hof
🇩🇪Hof, Germany
Schwerpunktpraxis fuer Haematologie und Onkologie
🇩🇪Saarbruecken, Germany
Southwest German Cancer Center at Eberhard-Karls-University
🇩🇪Tuebingen, Germany
Klinikum des Landkreises Loebau-Zittau GmbH
🇩🇪Zittau, Germany
St. Johannes Hospital - Medical Klinik II
🇩🇪Duisburg, Germany
Haematologische Praxis - Moenchengladbach
🇩🇪Moenchengladbach, Germany