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Chronic Lymphocytic LeukemiaPhase 3NCT00262795

Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

A Phase 3 study testing Fludarabine and Chlorambucil in people with Chronic Lymphocytic Leukemia, run by German CLL Study Group at 88 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether fludarabine is more effective than chlorambucil in treating chronic lymphocytic leukemia. Read more about this study

Who is it for?
Ages 65 to 79 years
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Fludarabine and Chlorambucil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
206 participants
Where
88 sitesin 2 countries
Study dates
Sep 2003to Oct 2005
Phase
Phase 3
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 65 to 79 years
  • All sexes
  • No healthy volunteers
  • Older adult

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of chronic lymphocytic leukemia, meeting any of the following staging criteria:
  • Binet stage A with B symptoms
  • Binet stage B or C, meeting 1 of the following criteria:
  • Rapid disease progression
  • Enlarged lymph nodes and organs
  • Severe B symptoms
  • Previously untreated disease

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2

Life expectancy

  • More than 6 months

Hematopoietic

  • No thrombocytopenia
  • No autoimmune hemolytic anemia

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No severe organ dysfunction
  • No other prior or concurrent neoplasm

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No prior chemotherapy
  • No other concurrent chemotherapy

Trial locations and contacts

88 sites in 2 countries.

88 sites in 2 countries

Germany87 sites

  • Klinikum St. Marien

    Amberg, D-92224

  • Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

    Ansbach, 91522

  • Zentralklinikum Augsburg

    Augsburg, DOH-86156

  • Humaine - Clinic

    Bad Saarow, 15526

  • Krankenhaus Hohe Warte Mediziniche Klinik

    Bayreuth, 95445

  • Onkologisches Versorgungszentrum Friedrichshain

    Berlin, 10249

  • Internistische Gemeinschaftspraxis - Berlin

    Berlin, 14195

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, D-12200

  • Charite - Campus Virchow Klinikum

    Berlin, D-13353

  • Saint Josef - Hospital Bochum

    Bochum, 44791

  • Praxis Dres. F.& G. Doering

    Bremen, 28205

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, D-50924

  • Onkologische Schwerpunktpraxis

    Cottbus, D-03046

  • Onkologische Gemeinschaftspraxis - Dresden

    Dresden, 01127

  • Krankenhaus Benrath

    Düsseldorf, 40593

  • Hans - Susemihl - Krankenhaus

    Emden, D-26721

  • Kreiskrankenhaus Erding

    Erding, 85435

  • Internistische/Onkologische Praxis - Erfurt

    Erfurt, 99084

  • Helios Klinikum Erfurt

    Erfurt, 99089

  • Onkologische Schwerpunkt Praxis

    Erlangen, D-91052

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Evangelisches Krankenhaus Essen Werden

    Essen, D-45239

  • Gemeinschaftspraxis - Freiburg

    Freiburg im Breisgau, 79098

  • Klinikum Garmisch - Partenkirchen

    Garmisch-Partenkirchen, N 82467

  • Gemeinschaftspraxis Innere Medizin Hämatologie/Onkologie - Gera

    Gera, 07548

  • Internistische Praxis - Gerlingen

    Gerlingen, 70839

  • Internistische Praxisgemeinschaft

    Germering, 82110

  • Universitaetsklinikum Goettingen

    Göttingen, D-37075

  • Internistisch-Haematologische Gemeinschaftspraxis - Gustrow

    Güstrow, 18273

  • Internistische Praxis - Halle

    Halle, 06108

  • Internistische Gemeinschaftspraxis - Halle

    Halle, 06110

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, D-20246

  • St. Marien-Hospital Hamm - Klinik Knappenstrasse

    Hamm, D-59071

  • Schwerpunktpraxis Haematologie/Onkologie - Hannover

    Hanover, 30169

  • Eichsfeld Klinikum gGmbH

    Heiligenstadt, 37339

  • Medizinischen Klinik Dr. R. Schindlbeck

    Herrsching am Ammersee, 82211

  • Oncological Specialist Practice

    Hildesheim, 31134

  • Universitaetsklinikum des Saarlandes

    Homburg, D-66421

  • Clinic for Bone Marrow Transplantation and Hematology and Oncology

    Idar-Oberstein, D-55743

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, D-67653

  • Staedt Klinikum Karlsruhe GGMBH

    Karlsruhe, 76133

  • Internistische Gemeinschaftspraxis - Kassel

    Kassel, 34117

  • Staedtische Krankenhaus Kiel

    Kiel, 23116

  • Krankenhaus Maria-Hilf Krefeld

    Krefeld, 47805

  • Internistische Onkologische Praxis - Kronach

    Kronach, 96317

  • Internistische Praxis - Landshut

    Landshut, 84028

  • Klinikum Lippe - Lemgo

    Lemgo, D-32657

  • Kreiskrankenhaus Luedenscheid

    Lüdenscheid, 58515

  • Internistische Praxis - Ludwigsburg

    Ludwigsburg, 71638

  • III Medizinische Klinik Mannheim

    Mannheim, D-68305

  • Regional Hospital Munchberg

    Munchber, D-95213

  • Hamatologie/Onkologie Praxisgemeinschaft - Munchen

    München, 81245

  • Klinikum Innenstadt

    Munich, 80331

  • Krankenhaus Muenchen Schwabing

    Munich, 80804

  • Hamatologische Schwerpunktpraxis

    Munich, 81679

  • Munich Oncologic Practice at Elisenhof

    Munich, D-80335

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Staedtisches Krankenhaus Muenchen - Harlaching

    Munich, D-81545

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

  • Haematologisch-onkologische Gemeinschaftspraxis - Muenster

    Münster, 48149

  • Onkologische Schwerpunktpraxis Dr. Schmidt

    Neunkirchen, D-66538

  • Praxis fuer Haematologie und Interne Onkologie

    Norderstedt, 22844

  • Praxisklinik fuer Innere Medizin - Nuernberg

    Nuremberg, 90449

  • Klinikum Nuernberg - Klinikum Nord

    Nuremberg, D-90419

  • Internistische Gemeinschaftspraxis - Oberstaufen

    Oberstaufen, 87534

  • Internistische Gemeinschaftspraxis - Offenbach

    Offenbach, 63065

  • Internistische Gemeinschaftspraxis - Oldenburg

    Oldenburg, 26121

  • Klinikum Ernst Von Bergmann

    Postdam, D-14467

  • Haematologische/Onkologische Schwerpunktpraxis - Rostock

    Rostock, 18057

  • Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

    Rostock, D-18057

  • Internistische Schwerpunktpraxis

    Rüsselsheim am Main, 65428

  • Internistische Gemeinschaftspraxis - Saarbruecken

    Saarbrücken, 66121

  • Caritasklinik St. Theresia

    Saarbrücken, D-66113

  • Schwerpunktpraxis Fuer Haematologie Und Onkologie

    Saarbruecke, N-66113

  • Kliniken Landkreis Sigmaringen GMBH

    Sigmaringen, D-72488

  • Internistische Gemeinschaftspraxis - Stuttgart

    Stuttgart, 70176

  • Marienhospital Stuttgart

    Stuttgart, 70199

  • Haematologische Praxis

    Stuttgart, D-70173

  • Klinik fuer Onkologie - Katharinenhospital Stuttgart

    Stuttgart, D-70174

  • Onkologische Gemeinschaftspraxis - Trier

    Trier, 54290

  • Krankenanstalt Mutterhaus der Borromaerinnen

    Trier, D-54290

  • Southwest German Cancer Center at Eberhard-Karls-University

    Tübingen, D-72076

  • Universitaetsklinikum Ulm

    Ulm, D-89081

  • St. Marien Hospital

    Vechta, D-49377

  • Gemeinschaftspraxis

    Worms, DOH-67547

  • Kliniken St. Antonius

    Wuppertal, D-42283

  • Hamatologisch - Onkologische Praxis Wurzburg

    Würzburg, 97070

Other trials in Germany

Austria1 site

  • Hanuschkrankenhaus

    Vienna, A-1140

Other trials in Austria

About this study

Official title: Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy, such as fludarabine and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether fludarabine is more effective than chlorambucil in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works as first-line therapy compared to chlorambucil in treating older patients with previously untreated chronic lymphocytic leukemia.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the overall and progression-free survival of older patients with previously untreated chronic lymphocytic leukemia treated with fludarabine vs chlorambucil.
  • Compare the duration of remission in patients treated with these regimens.

Secondary

  • Compare the incidence of toxicity, especially infections, in patients treated with these regimens.
  • Compare the quality of life in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive fludarabine IV on days 1-5. Treatment repeats every 28 days for up to 6 courses.
  • Arm II: Patients receive oral chlorambucil on day 1. Treatment repeats every 15 days for up to 12 months.

PROJECTED ACCRUAL: A total of 205 patients will be accrued for this study.

Being tested
Fludarabine, Chlorambucil
Keywords
stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • FludarabineDrug

    Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles

  • ChlorambucilDrug

    Chlorambucil p.o. (0,4 mg - max. 0,8 mg/kg/d, d1) q15d, max. 12 month

Study groups in NCT00262795
Study groupRoleWhat they receive
FExperimentalFludarabine
Receives: Drug: Fludarabine
CLBActive comparatorChlorambucil
Receives: Drug: Chlorambucil

Timeline

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

  1. First posted7 Dec 2005 (estimated)
  2. Study startSep 2003
  3. Primary completionJan 2005
  4. Study completionOct 2005

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00262795
Sponsor's protocol ID
CLL5
Other IDs
EU-20557, MEDAC-GCLLSG-CLL5, GCLLSG-73
Status last verified
May 2019
First submitted
6 Dec 2005
Last updated
23 May 2019
Results posted
No

Publications

  • Eichhorst BF, Fischer K, Fink AM, Elter T, Wendtner CM, Goede V, Bergmann M, Stilgenbauer S, Hopfinger G, Ritgen M, Bahlo J, Busch R, Hallek M; German CLL Study Group (GCLLSG). Limited clinical relevance of imaging techniques in the follow-up of patients with advanced chronic lymphocytic leukemia: results of a meta-analysis. Blood. 2011 Feb 10;117(6):1817-21. doi: 10.1182/blood-2010-04-282228. Epub 2010 Dec 7.

    PubMed 21139079

  • Cramer P, Bahlo J, Eichhorst B, Fischer K, Hallek M. Extramedullary manifestations of chronic lymphocytic leukaemia are not unusual. Leuk Res. 2014 Mar;38(3):284-5. doi: 10.1016/j.leukres.2013.11.015. Epub 2013 Dec 1. No abstract available.

    PubMed 24412156

  • Goede V, Cramer P, Busch R, Bergmann M, Stauch M, Hopfinger G, Stilgenbauer S, Dohner H, Westermann A, Wendtner CM, Eichhorst B, Hallek M; German CLL Study Group. Interactions between comorbidity and treatment of chronic lymphocytic leukemia: results of German Chronic Lymphocytic Leukemia Study Group trials. Haematologica. 2014 Jun;99(6):1095-100. doi: 10.3324/haematol.2013.096792. Epub 2014 Feb 28.

    PubMed 24584349

  • Sachanas S, Pangalis GA, Fink AM, Bahlo J, Fischer K, Levidou G, Kyrtsonis MC, Bartzi V, Vassilakopoulos TP, Kalpadakis C, Koulieris E, Moschogiannis M, Yiakoumis X, Tsirkinidis P, Angelopoulou MK, Eichhorst B, Hallek M. Small Lymphocytic Lymphoma: Analysis of Two Cohorts Including Patients in Clinical Trials of the German Chronic Lymphocytic Leukemia Study Group (GCLLSG) or in "Real-Life" Outside of Clinical Trials. Anticancer Res. 2019 May;39(5):2591-2598. doi: 10.21873/anticanres.13382.

    PubMed 31092457

  • Eichhorst BF, Busch R, Stilgenbauer S, Stauch M, Bergmann MA, Ritgen M, Kranzhofer N, Rohrberg R, Soling U, Burkhard O, Westermann A, Goede V, Schweighofer CD, Fischer K, Fink AM, Wendtner CM, Brittinger G, Dohner H, Emmerich B, Hallek M; German CLL Study Group (GCLLSG). First-line therapy with fludarabine compared with chlorambucil does not result in a major benefit for elderly patients with advanced chronic lymphocytic leukemia. Blood. 2009 Oct 15;114(16):3382-91. doi: 10.1182/blood-2009-02-206185. Epub 2009 Jul 15.

    PubMed 19605849

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fludarabine and Chlorambucil in people with Chronic Lymphocytic Leukemia, run by German CLL Study Group at 88 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 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00262795, which also lists 5 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 23 May 2019.

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