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

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ClinicalTrials.gov Identifier: NCT00278213
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : October 3, 2016
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Prolymphocytic Leukemia Biological: alemtuzumab Drug: cyclophosphamide Drug: fludarabine phosphate Drug: mitoxantrone hydrochloride Phase 2

Detailed Description:



  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Consolidation With Campath-1H After FMC Induction in Patients With T-cell Chronic Lymphocytic Leukemia
Study Start Date : September 2002
Primary Completion Date : February 2007
Study Completion Date : December 2009

Primary Outcome Measures :
  1. Adverse effects at 2 months after treatment
  2. Remission rate at 2 months after treatment

Secondary Outcome Measures :
  1. Overall survival at 2 months after treatment
  2. Progression-free survival at 2 months after treatment
  3. Remission quality at 2 months after treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics
  • No prior fludarabine, mitoxantrone hydrochloride, cyclophosphamide, or alemtuzumab

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Universitaetsklinikum Essen
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
Dr. Horst-Schmidt-Kliniken
Wiesbaden, Germany, D-65199
Hamatologisch - Onkologische Praxis Wurzburg
Wurzburg, Germany, 97070
Klinikum des Landkreises Loebau-Zittau GmbH
Zittau, Germany, 02763
Sponsors and Collaborators
German CLL Study Group
Study Chair: Georg Hopfinger Hanusch-Krankenhaus

Additional Information:
ClinicalTrials.gov Identifier: NCT00278213     History of Changes
Other Study ID Numbers: T-PLL1
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by German CLL Study Group:
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

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Prolymphocytic
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors