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| ID | Type | Description | Link |
|---|---|---|---|
| EU-20562 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alemtuzumab | Biological | |||
| cyclophosphamide | Drug | |||
| fludarabine phosphate | Drug | |||
| mitoxantrone hydrochloride | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects at 2 months after treatment | ||
| Remission rate at 2 months after treatment |
| 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 |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Georg Hopfinger | Hanusch-Krankenhaus | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allgemeines Krankenhaus - Universitatskliniken | Vienna | A-1090 | Austria | |||
| Hanuschkrankenhaus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23512246 | Result | Hopfinger G, Busch R, Pflug N, Weit N, Westermann A, Fink AM, Cramer P, Reinart N, Winkler D, Fingerle-Rowson G, Stilgenbauer S, Dohner H, Kandler G, Eichhorst B, Hallek M, Herling M. Sequential chemoimmunotherapy of fludarabine, mitoxantrone, and cyclophosphamide induction followed by alemtuzumab consolidation is effective in T-cell prolymphocytic leukemia. Cancer. 2013 Jun 15;119(12):2258-67. doi: 10.1002/cncr.27972. Epub 2013 Mar 19. |
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| Vienna |
| A-1140 |
| Austria |
| Allgemeinen Krankenhaus Celle Kinderklinik | Celle | 29223 | Germany |
| St. Johannes Hospital - Medical Klinik II | Duisburg | D-47166 | Germany |
| Helios Klinikum Erfurt | Erfurt | D-99089 | Germany |
| Universitaetsklinikum Essen | Essen | D-45147 | Germany |
| Klinikum Garmisch - Partenkirchen GmbH | Garmisch-Partenkirchen | N 82467 | Germany |
| Sana Klinikum Hof | Hof | 95032 | Germany |
| University Hospital Schleswig-Holstein - Kiel Campus | Kiel | D-24116 | Germany |
| Internistische Praxis - Ludwigsburg | Ludwigsburg | 71638 | Germany |
| Sana Kliniken Luebeck | Lübeck | D-23560 | Germany |
| Haematologische Praxis - Moenchengladbach | Mönchengladbach | 41239 | Germany |
| Gemeinschaftliche Schwerpunktpraxis - Osnabrueck | Osnabrück | 49074 | Germany |
| Schwerpunktpraxis fuer Haematologie und Onkologie | Saarbrücken | 66113 | Germany |
| Caritasklinik St. Theresia | Saarbrücken | D-66113 | Germany |
| Southwest German Cancer Center at Eberhard-Karls-University | Tübingen | D-72076 | Germany |
| Dr. Horst-Schmidt-Kliniken | Wiesbaden | D-65199 | Germany |
| Hamatologisch - Onkologische Praxis Wurzburg | Würzburg | 97070 | Germany |
| Klinikum des Landkreises Loebau-Zittau GmbH | Zittau | 02763 | Germany |
| ID | Term |
|---|---|
| D015463 | Leukemia, Prolymphocytic |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D054066 | Leukemia, Large Granular Lymphocytic |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015458 | Leukemia, T-Cell |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| D003520 | Cyclophosphamide |
| C042382 | fludarabine phosphate |
| D008942 | Mitoxantrone |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
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