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

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
alemtuzumab
Sponsored by
German CLL Study Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring refractory chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allgemeines Krankenhaus der Stadt Wien
  • Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
  • Specialist Practice for Oncology
  • Humaine - Clinic
  • Haematolo-Onkologische Schwerpunktpraxis - Berlin
  • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
  • Hospital Kuchwald Chemnitz
  • Universitaetsklinikum Essen
  • Staedtische Kliniken Esslingen
  • Krankenhaus Nordwest
  • Universitaetsklinikum Freiburg
  • Universitaetsklinikum Goettingen
  • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
  • St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
  • Internistische Gemeinschaftspraxis - Halle
  • Praxis fur Innere Medizin - Hamburg
  • Asklepios Klinik St. Georg
  • Evangelische Krankenhaus Hamm
  • Medizinische Hochschule Hannover
  • Universitaets-Kinderklinik Heidelberg
  • Marienhospital at Ruhr University Bochum
  • Universitaetsklinikum des Saarlandes
  • Clinic for Bone Marrow Transplantation and Hematology and Oncology
  • Internistische Gemeinschaftspraxis - Kassel
  • University Hospital Schleswig-Holstein - Kiel Campus
  • Internistische Praxis - Landshut
  • Klinikum Lippe - Lemgo
  • III Medizinische Klinik Mannheim
  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen
  • Klinikum Oldenburg
  • St. Marien - Krankenhaus Siegen GMBH
  • Southwest German Cancer Center at Eberhard-Karls-University
  • Universitaetsklinikum Ulm
  • Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
  • Hamatologisch - Onkologische Praxis Wurzburg

Outcomes

Primary Outcome Measures

Safety and efficacy
Response

Secondary Outcome Measures

Full Information

First Posted
January 10, 2006
Last Updated
November 5, 2013
Sponsor
German CLL Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00274976
Brief Title
Alemtuzumab in Treating Patients With Advanced Chronic Lymphocytic Leukemia That Did Not Respond to Previous Fludarabine
Official Title
Subcutaneous Campath-1H in Fludarabine-Refractory CLL
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
German CLL Study Group

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
refractory chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
alemtuzumab
Primary Outcome Measure Information:
Title
Safety and efficacy
Title
Response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Stilgenbauer, MD
Organizational Affiliation
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Facility Information:
Facility Name
Allgemeines Krankenhaus der Stadt Wien
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
City
Ansbach
ZIP/Postal Code
91522
Country
Germany
Facility Name
Specialist Practice for Oncology
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Humaine - Clinic
City
Bad Saarow
ZIP/Postal Code
15526
Country
Germany
Facility Name
Haematolo-Onkologische Schwerpunktpraxis - Berlin
City
Berlin
ZIP/Postal Code
13357
Country
Germany
Facility Name
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
City
Berlin
ZIP/Postal Code
D-13122
Country
Germany
Facility Name
Hospital Kuchwald Chemnitz
City
Chemnitz
ZIP/Postal Code
09113
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Staedtische Kliniken Esslingen
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Krankenhaus Nordwest
City
Frankfurt
ZIP/Postal Code
D-60488
Country
Germany
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
Universitaetsklinikum Goettingen
City
Goettingen
ZIP/Postal Code
D-37075
Country
Germany
Facility Name
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
City
Greifswald
ZIP/Postal Code
D-17487
Country
Germany
Facility Name
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
City
Hagen
ZIP/Postal Code
58095
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Halle
City
Halle
ZIP/Postal Code
06110
Country
Germany
Facility Name
Praxis fur Innere Medizin - Hamburg
City
Hamburg
ZIP/Postal Code
22457
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
D-20099
Country
Germany
Facility Name
Evangelische Krankenhaus Hamm
City
Hamm
ZIP/Postal Code
DOH-59063
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
D-30625
Country
Germany
Facility Name
Universitaets-Kinderklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
Facility Name
Marienhospital at Ruhr University Bochum
City
Herne
ZIP/Postal Code
D-44625
Country
Germany
Facility Name
Universitaetsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
D-66421
Country
Germany
Facility Name
Clinic for Bone Marrow Transplantation and Hematology and Oncology
City
Idar-Oberstein
ZIP/Postal Code
D-55743
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Kassel
City
Kassel
ZIP/Postal Code
34117
Country
Germany
Facility Name
University Hospital Schleswig-Holstein - Kiel Campus
City
Kiel
ZIP/Postal Code
D-24105
Country
Germany
Facility Name
Internistische Praxis - Landshut
City
Landshut
ZIP/Postal Code
84028
Country
Germany
Facility Name
Klinikum Lippe - Lemgo
City
Lemgo
ZIP/Postal Code
D-32657
Country
Germany
Facility Name
III Medizinische Klinik Mannheim
City
Mannheim
ZIP/Postal Code
D-68305
Country
Germany
Facility Name
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
City
Munich
ZIP/Postal Code
D-81675
Country
Germany
Facility Name
Klinikum Oldenburg
City
Oldenburg
ZIP/Postal Code
D-26133
Country
Germany
Facility Name
St. Marien - Krankenhaus Siegen GMBH
City
Siegen
ZIP/Postal Code
D-57072
Country
Germany
Facility Name
Southwest German Cancer Center at Eberhard-Karls-University
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
D-89081
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
City
Wuerzburg
ZIP/Postal Code
D-
Country
Germany
Facility Name
Hamatologisch - Onkologische Praxis Wurzburg
City
Wurzburg
ZIP/Postal Code
97070
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19597025
Citation
Stilgenbauer S, Zenz T, Winkler D, Buhler A, Schlenk RF, Groner S, Busch R, Hensel M, Duhrsen U, Finke J, Dreger P, Jager U, Lengfelder E, Hohloch K, Soling U, Schlag R, Kneba M, Hallek M, Dohner H; German Chronic Lymphocytic Leukemia Study Group. Subcutaneous alemtuzumab in fludarabine-refractory chronic lymphocytic leukemia: clinical results and prognostic marker analyses from the CLL2H study of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2009 Aug 20;27(24):3994-4001. doi: 10.1200/JCO.2008.21.1128. Epub 2009 Jul 13.
Results Reference
result
PubMed Identifier
19643983
Citation
Zenz T, Habe S, Denzel T, Mohr J, Winkler D, Buhler A, Sarno A, Groner S, Mertens D, Busch R, Hallek M, Dohner H, Stilgenbauer S. Detailed analysis of p53 pathway defects in fludarabine-refractory chronic lymphocytic leukemia (CLL): dissecting the contribution of 17p deletion, TP53 mutation, p53-p21 dysfunction, and miR34a in a prospective clinical trial. Blood. 2009 Sep 24;114(13):2589-97. doi: 10.1182/blood-2009-05-224071. Epub 2009 Jul 30.
Results Reference
result
Citation
Stilgenbauer S, Zenz T, Winkler D, et al.: Subcutaneous alemtuzumab (Campath) in fludarabine-refractory CLL: final results of the CLL2H trial of the GCLLSG and comprehensive analysis of prognostic markers. [Abstract] Blood 112 (11): A-329, 2008.
Results Reference
result
PubMed Identifier
23821658
Citation
Schnaiter A, Paschka P, Rossi M, Zenz T, Buhler A, Winkler D, Cazzola M, Dohner K, Edelmann J, Mertens D, Kless S, Mack S, Busch R, Hallek M, Dohner H, Stilgenbauer S. NOTCH1, SF3B1, and TP53 mutations in fludarabine-refractory CLL patients treated with alemtuzumab: results from the CLL2H trial of the GCLLSG. Blood. 2013 Aug 15;122(7):1266-70. doi: 10.1182/blood-2013-03-488197. Epub 2013 Jul 2.
Results Reference
derived

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

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