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AzTrials

LeukemiaPhase 2NCT00274976

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

A Phase 2 study testing alemtuzumab in people with Leukemia, run by German CLL Study Group at 35 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Leukemia
What is being tested?
alemtuzumab
How many people
Not given
Where
35 sitesin 2 countries
Study dates
Sep 2002to Aug 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

Germany34 sites

  • Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

    Ansbach, 91522

  • Specialist Practice for Oncology

    Aschaffenburg, 63739

  • Humaine - Clinic

    Bad Saarow, 15526

  • Haematolo-Onkologische Schwerpunktpraxis - Berlin

    Berlin, 13357

  • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

    Berlin, D-13122

  • Hospital Kuchwald Chemnitz

    Chemnitz, 09113

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Staedtische Kliniken Esslingen

    Esslingen am Neckar, 73730

  • Krankenhaus Nordwest

    Frankfurt, D-60488

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, D-79106

  • Universitaetsklinikum Goettingen

    Göttingen, D-37075

  • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

    Greifswald, D-17487

  • St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

    Hagen, 58095

  • Internistische Gemeinschaftspraxis - Halle

    Halle, 06110

  • Praxis fur Innere Medizin - Hamburg

    Hamburg, 22457

  • Asklepios Klinik St. Georg

    Hamburg, D-20099

  • Evangelische Krankenhaus Hamm

    Hamm, DOH-59063

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Universitaets-Kinderklinik Heidelberg

    Heidelberg, D-69120

  • Marienhospital at Ruhr University Bochum

    Herne, D-44625

  • Universitaetsklinikum des Saarlandes

    Homburg, D-66421

  • Clinic for Bone Marrow Transplantation and Hematology and Oncology

    Idar-Oberstein, D-55743

  • Internistische Gemeinschaftspraxis - Kassel

    Kassel, 34117

  • University Hospital Schleswig-Holstein - Kiel Campus

    Kiel, D-24105

  • Internistische Praxis - Landshut

    Landshut, 84028

  • Klinikum Lippe - Lemgo

    Lemgo, D-32657

  • III Medizinische Klinik Mannheim

    Mannheim, D-68305

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

  • Klinikum Oldenburg

    Oldenburg, D-26133

  • St. Marien - Krankenhaus Siegen GMBH

    Siegen, D-57072

  • Southwest German Cancer Center at Eberhard-Karls-University

    Tübingen, D-72076

  • Universitaetsklinikum Ulm

    Ulm, D-89081

  • Hamatologisch - Onkologische Praxis Wurzburg

    Würzburg, 97070

  • Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg

    Würzburg, D-

Other trials in Germany

Austria1 site

  • Allgemeines Krankenhaus der Stadt Wien

    Vienna, A-1090

Other trials in Austria

About this study

Official title: Subcutaneous Campath-1H in Fludarabine-Refractory CLL

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.

Read the 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.

Conditions
Leukemia
Being tested
alemtuzumab
Keywords
refractory chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia
Medical subject headings
Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alemtuzumabBiological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and efficacy

  2. Response

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2006 (estimated)
  2. Study startSep 2002
  3. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00274976
Sponsor's protocol ID
CDR0000455059
Other IDs
GCLLSG-CLL2H, EU-20550, MEDAC-GCLLSG-CLL2H, AMGEN-GCLLSG-CLL2H
Status last verified
May 2006
First submitted
10 Jan 2006
Last updated
6 Nov 2013
Results posted
No

Publications

  • 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.

    PubMed 19597025

  • 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.

    PubMed 19643983

  • 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.

  • 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.

    PubMed 23821658

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing alemtuzumab in people with Leukemia, run by German CLL Study Group at 35 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and efficacy. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00274976, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.

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