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Alemtuzumab in Treating Patients With Advanced Chronic Lymphocytic Leukemia That Did Not Respond to Previous Fludarabine

Sponsor
German CLL Study Group (Other)
Overall Status
Completed
CT.gov ID
NCT00274976
Collaborator
(none)
35
Locations
83
Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.

PURPOSE: This phase II trial is studying how well giving alemtuzumab by injection works in treating patients with advanced chronic lymphocytic leukemia that did not respond to previous fludarabine.

Condition or Disease Intervention/Treatment Phase
  • Biological: alemtuzumab
 Phase 2

Detailed Description

OBJECTIVES:

  • Compare the safety and efficacy of subcutaneous alemtuzumab vs intravenous alemtuzumab in patients with fludarabine-refractory advanced chronic lymphocytic leukemia.

  • Determine the response in patients with high-risk genetic abnormalities (unmutated immunoglobulin variable heavy-chain [IgVH] status, del [17p], del [11q]) treated with subcutaneous alemtuzumab after progression on fludarabine.

OUTLINE: This is a multicenter study.

Patients receive alemtuzumab IV once, followed 1 week later by alemtuzumab subcutaneously once weekly for up to 12 weeks.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Subcutaneous Campath-1H in Fludarabine-Refractory CLL
Study Start Date :
Sep 1, 2002
Actual Study Completion Date :
Aug 1, 2009

Outcome Measures

Primary Outcome Measures

  1. Safety and efficacy []

  2. Response []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of previously treated advanced chronic lymphocytic leukemia (CLL)

  • Fludarabine-refractory disease

  • Requires treatment

PATIENT CHARACTERISTICS:

  • Life expectancy more than 6 months

  • ECOG 0-2

  • No severe organ dysfunction

  • No other concomitant or previous neoplasms

  • No autoimmune hemolytic anemia or thrombocytopenia

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • Up to 5 prior chemotherapy regimens allowed

Contacts and Locations

Locations

Site City State Country Postal Code
1 Allgemeines Krankenhaus der Stadt Wien Vienna Austria A-1090
2 Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie Ansbach Germany 91522
3 Specialist Practice for Oncology Aschaffenburg Germany 63739
4 Humaine - Clinic Bad Saarow Germany 15526
5 Haematolo-Onkologische Schwerpunktpraxis - Berlin Berlin Germany 13357
6 Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch Berlin Germany D-13122
7 Hospital Kuchwald Chemnitz Chemnitz Germany 09113
8 Universitaetsklinikum Essen Essen Germany D-45122
9 Staedtische Kliniken Esslingen Esslingen Germany 73730
10 Krankenhaus Nordwest Frankfurt Germany D-60488
11 Universitaetsklinikum Freiburg Freiburg Germany D-79106
12 Universitaetsklinikum Goettingen Goettingen Germany D-37075
13 Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet Greifswald Germany D-17487
14 St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH Hagen Germany 58095
15 Internistische Gemeinschaftspraxis - Halle Halle Germany 06110
16 Praxis fur Innere Medizin - Hamburg Hamburg Germany 22457
17 Asklepios Klinik St. Georg Hamburg Germany D-20099
18 Evangelische Krankenhaus Hamm Hamm Germany DOH-59063
19 Medizinische Hochschule Hannover Hannover Germany D-30625
20 Universitaets-Kinderklinik Heidelberg Heidelberg Germany D-69120
21 Marienhospital at Ruhr University Bochum Herne Germany D-44625
22 Universitaetsklinikum des Saarlandes Homburg Germany D-66421
23 Clinic for Bone Marrow Transplantation and Hematology and Oncology Idar-Oberstein Germany D-55743
24 Internistische Gemeinschaftspraxis - Kassel Kassel Germany 34117
25 University Hospital Schleswig-Holstein - Kiel Campus Kiel Germany D-24105
26 Internistische Praxis - Landshut Landshut Germany 84028
27 Klinikum Lippe - Lemgo Lemgo Germany D-32657
28 III Medizinische Klinik Mannheim Mannheim Germany D-68305
29 Klinikum Rechts Der Isar - Technische Universitaet Muenchen Munich Germany D-81675
30 Klinikum Oldenburg Oldenburg Germany D-26133
31 St. Marien - Krankenhaus Siegen GMBH Siegen Germany D-57072
32 Southwest German Cancer Center at Eberhard-Karls-University Tuebingen Germany D-72076
33 Universitaetsklinikum Ulm Ulm Germany D-89081
34 Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg Wuerzburg Germany D-
35 Hamatologisch - Onkologische Praxis Wurzburg Wurzburg Germany 97070

Sponsors and Collaborators

  • German CLL Study Group

Investigators

  • : Stephan Stilgenbauer, MD, Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00274976
Other Study ID Numbers:
  • CDR0000455059
  • GCLLSG-CLL2H
  • EU-20550
  • MEDAC-GCLLSG-CLL2H
  • AMGEN-GCLLSG-CLL2H
First Posted:
Jan 11, 2006
Last Update Posted:
Nov 6, 2013
Last Verified:
May 1, 2006
Keywords provided by , ,
refractory chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Alemtuzumab

Study Results

No Results Posted as of Nov 6, 2013