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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00278213
First received: January 16, 2006
Last updated: November 5, 2013
Last verified: July 2007
  Purpose

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 Intervention Phase
Leukemia
Biological: alemtuzumab
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: mitoxantrone hydrochloride
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Adverse effects at 2 months after treatment [ Designated as safety issue: Yes ]
  • Remission rate at 2 months after treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 17
Study Start Date: September 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278213

Locations
Austria
Allgemeines Krankenhaus - Universitatskliniken
Vienna, Austria, A-1090
Hanuschkrankenhaus
Vienna, Austria, A-1140
Germany
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
Investigators
Study Chair: Georg Hopfinger Hanusch-Krankenhaus
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00278213     History of Changes
Other Study ID Numbers: CDR0000454588, GCLLSG-T-PLL1, EU-20562
Study First Received: January 16, 2006
Last Updated: November 5, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
Leukemia
Leukemia, Prolymphocytic, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Leukemia, T-Cell
Cyclophosphamide
Fludarabine phosphate
Fludarabine
Alemtuzumab
Mitoxantrone
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Analgesics

ClinicalTrials.gov processed this record on September 16, 2014