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Chronic Lymphocytic LeukemiaPhase 3NCT00262782

Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia

A Phase 3 study testing Fludarabine in people with Chronic Lymphocytic Leukemia, run by German CLL Study Group at 117 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, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes, the cancer may not need treatment until it progresses. In this case, observation may be sufficient. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Fludarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
877 participants
Where
117 sitesin 2 countries
Study dates
Apr 1997to Jun 2010
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Confirmed diagnosis of B-cell chronic lymphocytic leukemia
  • Rai stage 0-II (Binet stage A) disease
  • Meets 1 of the following criteria:
  • High-risk disease, as defined by the following:
  • Serum thymidine kinase level > 7.0 U/L
  • Elevated β2-microglobulin level
  • Presence of non-nodular bone marrow infiltration
  • Short lymphocyte doubling time
  • Low-risk disease
  • Meets none of the criteria (as listed above) for high-risk disease

PATIENT CHARACTERISTICS:

Performance status

  • Not specified

Life expectancy

  • More than 6 months

Hematopoietic

  • No autoimmune hemolytic anemia
  • No thrombocytopenia

Hepatic

  • Not specified

Renal

  • Not specified

Other

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

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No prior chemotherapy
  • No other concurrent chemotherapy

Trial locations and contacts

117 sites in 2 countries.

117 sites in 2 countries

Germany115 sites

  • Klinikum St. Marien

    Amberg, D-92224

  • Internistische Praxis - Arnstadt

    Arnstadt, 99310

  • Zentralklinikum Augsburg

    Augsburg, DOH-86156

  • Kreiskrankenhaus Aurich

    Aurich, D-26603

  • Regional Hospital Am Plattenwald

    Bad Friedrichshall, 74172

  • Regional Hospital Bad Hersfeld

    Bad Hersfeld, 36251

  • Arzt fuer Innere Medizin - Bad Reichenhall

    Bad Reichenhall, 83435

  • Humaine - Clinic

    Bad Saarow, 15526

  • Ermstalklinik Bad Urach

    Bad Urach, D-72574

  • Internistische Praxis - Berlin

    Berlin, 10969

  • Internistische Gemeinschaftspraxis - Berlin

    Berlin, 13347

  • Haematologisch-Onkologische Schwerpunktpraxis

    Berlin, 13357

  • Internistische Praxis - Berlin

    Berlin, 14052

  • Internistische Gemeinschaftspraxis - Berlin

    Berlin, 14195

  • Charite - Campus Charite Mitte

    Berlin, D-10117

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, D-12200

  • Charite - Campus Virchow Klinikum

    Berlin, D-13353

  • Gemeinschaftspraxis - Betzdorf

    Betzdorf, 57518

  • Praxis Dres. F.& G. Doering

    Bremen, 28205

  • Krankenhaus Burglengenfeld

    Burglengenfeld, 93133

  • Praxis Fuer Haematologie Internistische Onkologie

    Cologne, D-50677

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, D-50924

  • Onkologische Schwerpunktpraxis

    Cottbus, D-03046

  • Staedtisches Klinikum Dessau

    Dessau, D-06847

  • Onkologische Gemeinschaftspraxis - Dresden

    Dresden, 01127

  • Michael Schaefers und Partner

    Duisburg, D-47051

  • Universitaetsklinik Duesseldorf

    Düsseldorf, D-40225

  • Internistische Gemeinschaftpraxis - Ehingen

    Ehingen, 89584

  • Onkologische Schwerpunktpraxis - Erding

    Erding, 85435

  • Internistische/Onkologische Praxis - Erfurt

    Erfurt, 99084

  • Onkologische Schwerpunkt Praxis

    Erlangen, D-91052

  • St. Antonius Hospital

    Eschweiler, DOH-52249

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Staedtische Kliniken Esslingen

    Esslingen am Neckar, 73730

  • Internistische Gemeinschaftspraxis - Forchheim

    Forchheim, 91301

  • Klinikum Garmisch - Partenkirchen

    Garmisch-Partenkirchen, N 82467

  • Gemeinschaftspraxis - Germering

    Germering, 82110

  • Internistische Praxisgemeinschaft

    Germering, 82110

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

    Greifswald, D-17487

  • Onkologische Gemeinschaftspraxis - Gross-Gerau

    Groß-Gerau, 64521

  • St. Marien Hospital at Katholisches Krankenhaus hagen gem. GmbH

    Hagen, 58095

  • Allgemeines Krankenhaus Hagen

    Hagen, D-58095

  • Internistische Praxis - Halle

    Halle, 06108

  • Internistische Gemeinschaftspraxis - Halle

    Halle, 06110

  • Martin Luther Universitaet

    Halle, D-06097

  • Praxis fur Innere Medizin - Hamburg

    Hamburg, 22457

  • Allgemeines Krankenhaus St. Georg

    Hamburg, D-20099

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, D-20246

  • Schwerpunktpraxis Haematologie/Onkologie - Hannover

    Hanover, 30169

  • Facharzt fuer Allgemeinmedizin - Hausham

    Hausham, 83734

  • Facharzt fuer Innere Medizin - Hechingen

    Hechingen, 72379

  • Onkologische Schwerpunktpraxis Heidelberg

    Heidelberg, 69115

  • Universitatsklinikum Heidelberg

    Heidelberg, 69120

  • 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

  • Praxis am Evangelischen Krankenhaus Bethanien

    Iserlohn, D-58644

  • Internistische Gemeinschaftspraxis - Jena

    Jena, 07743

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, D-67653

  • Staedt Klinikum Karlsruhe GGMBH

    Karlsruhe, 76133

  • Facharzt Fuer Jnnere Medizin

    Karlsruhe, 76135

  • St. Vincentius-Kliniken

    Karlsruhe, D-76137

  • Internistische Gemeinschaftspraxis - Kassel

    Kassel, 34117

  • Staedtische Krankenhaus Kiel

    Kiel, 23116

  • Internistische Onkologische Praxis - Kronach

    Kronach, 96317

  • Internistische Praxis - Landshut

    Landshut, 84028

  • Onkologische Schwerpunktpraxis Leer

    Leer, D-26789

  • Klinikum Lippe - Lemgo

    Lemgo, D-32657

  • Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

    Magdeburg, D-39120

  • Gemeinschaftspraxis

    Mannheim, D-68161

  • Philipps-Universitaet Marburg Klinikum

    Marburg, D-35033

  • Internistische Gemeinschaftspraxis - Memmingen

    Memmingen, 87700

  • Klinikum Minden

    Minden, D-32427

  • Haematologische Praxis - Moenchengladbach

    Mönchengladbach, 41239

  • 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

  • Haematologisch-onkologische Gemeinschaftspraxis - Muenster

    Münster, 48149

  • Klinikum Garmisch-Partenkirchen GmbH Abteilung fuer Innere Medizin Murnau

    Murnau am Staffelsee, 82418

  • Internistische Praxis - Neuenkirchen

    Neuenkirchen, 48485

  • Onkologische Schwerpunktpraxis Dr. Schmidt

    Neunkirchen, D-66538

  • Praxis fuer Haematologie und Interne Onkologie

    Norderstedt, 22844

  • Sudharz-Krankenhaus Nordhausen gGmbH

    Nordhausen, 99734

  • Klinikum Nuernberg - Klinikum Nord

    Nuremberg, D-90419

  • Internistische Gemeinschaftspraxis - Offenbach

    Offenbach, 63065

  • Hematologische Praxis

    Oldenburg, 26121

  • Gemeinschaftliche Schwerpunktpraxis - Osnabrueck

    Osnabrück, 49074

  • Municipal Hospital Complex

    Pforzheim, D-75178

  • Hematologische Onkologische Praxis

    Regensburg, 93047

  • Jakobi Krankenhaus

    Rheine, 48431

  • Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

    Rostock, D-18057

  • Caritasklinik St. Theresia

    Saarbrücken, D-66113

  • Schwerpunktpraxis Fuer Haematologie Und Onkologie

    Saarbruecke, N-66113

  • Onkologische Schwerpunktpraxis - Schrobenhausen

    Schrobenhausen, 86529

  • Praxis - Schwenningen

    Schwenningen, 78054

  • St. Marien - Krankenhaus Siegen GMBH

    Siegen, D-57072

  • Evang. Jung-Stilling Hospital

    Siegen, D-57074

  • Praxisgemeinschaft - Stade

    Stade, 21680

  • Onkologische Schwerpunktpraxis - Straubing

    Straubing, 94315

  • Haematologische Praxis

    Stuttgart, D-70173

  • Diakonie Klinikum Stuttgart

    Stuttgart, D-70176

  • Onkologische Gemeinschaftspraxis - Trier

    Trier, 54290

  • Southwest German Cancer Center at Eberhard-Karls-University

    Tübingen, D-72076

  • Universitaetsklinikum Ulm

    Ulm, D-89081

  • St. Marien Hospital

    Vechta, D-49377

  • Gemeinschaftspraxis - Weiden

    Weiden, 92637

  • Haematologisch-Onkologische Schwerpunktpraxis - Weilheim

    Weilheim, 82362

  • Internistische Praxis - Wendlingen

    Wendlingen, 73240

  • Kliniken St. Antonius

    Wuppertal, D-42283

  • Hamatologisch - Onkologische Praxis Wurzburg

    Würzburg, 97070

  • Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg

    Würzburg, D-97070

Other trials in Germany

Austria2 sites

  • Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik

    Vienna, 1090

  • Hanuschkrankenhaus

    Vienna, A-1140

Other trials in Austria

About this study

Official title: Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes, the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether fludarabine is more effective than observation in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works compared to observation only in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.

Read the detailed description

OBJECTIVES:

  • Identify prognostic factors that predict a short survival in patients with stage 0-II B-cell chronic lymphocytic leukemia treated with fludarabine or observation only.

OUTLINE: This is a randomized study. Patients are stratified according to risk (high risk vs low risk). Patients in the low-risk group undergo observation only. Patients in the high-risk group are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive fludarabine.
  • Arm II: Patients undergo observation only.

PROJECTED ACCRUAL: A total of 880 patients will be accrued for this study.

Being tested
Fludarabine
Keywords
B-cell chronic lymphocytic leukemia, stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II 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

    Also called Fludura

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

Study groups in NCT00262782
Study groupRoleWhat they receive
FludarabineExperimentalNot described
Receives: Drug: Fludarabine
watch & waitNo interventionNot described

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 startApr 1997
  3. Primary completionDec 2004
  4. Study completionJun 2010

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
877 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00262782
Sponsor's protocol ID
CLL1
Other IDs
EU-20548, GCLLSG-138, MEDAC-GCLLSG-CLL1
Status last verified
Feb 2020
First submitted
6 Dec 2005
Last updated
20 Feb 2020
Results posted
No
Individual data sharing
No

Publications

  • Gobel M, Eisele L, Mollmann M, Huttmann A, Johansson P, Scholtysik R, Bergmann M, Busch R, Dohner H, Hallek M, Seiler T, Stilgenbauer S, Klein-Hitpass L, Duhrsen U, Durig J. Progranulin is a novel independent predictor of disease progression and overall survival in chronic lymphocytic leukemia. PLoS One. 2013 Aug 23;8(8):e72107. doi: 10.1371/journal.pone.0072107. eCollection 2013.

    PubMed 24009671

  • 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

  • Bergmann MA, Eichhorst BF, Busch R, et al.: Early and risk-adapted therapy with fludarabine in high-risk Binet stage A CLL patients prolongs progression free survival but not overall survival: results of the CLL1 protocol of the German CLL Study Group (GCLLSG). [Abstract] Blood 110 (11): A-2038, 2007.

  • Bergmann MA, Eichhorst BF, Busch R, et al.: Prospective evaluation of prognostic parameters in early stage chronic lymphocytic leukemia (CLL): results of the CLL1-protocol of the German CLL Study Group (GCLLSG). [Abstract] Blood 110 (11): A-625, 2007.

  • Hoechstetter MA, Busch R, Eichhorst B, Buhler A, Winkler D, Eckart MJ, Vehling-Kaiser U, Schimke H, Jager U, Hurtz HJ, Hopfinger G, Hartmann F, Fuss H, Abenhardt W, Blau I, Freier W, Muller L, Goebeler M, Wendtner CM, Bahlo J, Fischer K, Bentz M, Emmerich B, Dohner H, Hallek M, Stilgenbauer S. Early, risk-adapted treatment with fludarabine in Binet stage A chronic lymphocytic leukemia patients: results of the CLL1 trial of the German CLL study group. Leukemia. 2017 Dec;31(12):2833-2837. doi: 10.1038/leu.2017.246. Epub 2017 Aug 14. No abstract available.

    PubMed 28804126

  • Hoechstetter MA, Busch R, Eichhorst B, Buhler A, Winkler D, Bahlo J, Robrecht S, Eckart MJ, Vehling-Kaiser U, Jacobs G, Jager U, Hurtz HJ, Hopfinger G, Hartmann F, Fuss H, Abenhardt W, Blau I, Freier W, Muller L, Goebeler M, Wendtner C, Fischer K, Herling CD, Starck M, Bentz M, Emmerich B, Dohner H, Stilgenbauer S, Hallek M. Prognostic model for newly diagnosed CLL patients in Binet stage A: results of the multicenter, prospective CLL1 trial of the German CLL study group. Leukemia. 2020 Apr;34(4):1038-1051. doi: 10.1038/s41375-020-0727-y. Epub 2020 Feb 10.

    PubMed 32042081

  • Langerbeins P, Giza A, Robrecht S, Cramer P, von Tresckow J, Al-Sawaf O, Fink AM, Furstenau M, Kutsch N, Simon F, Goede V, Hoechstetter M, Niemann CU, da Cunha-Bang C, Kater A, Dubois J, Gregor M, Staber PB, Tausch E, Schneider C, Stilgenbauer S, Eichhorst B, Fischer K, Hallek M. Reassessing the chronic lymphocytic leukemia International Prognostic Index in the era of targeted therapies. Blood. 2024 Jun 20;143(25):2588-2598. doi: 10.1182/blood.2023022564.

    PubMed 38620092

  • Jaramillo S, Agathangelidis A, Schneider C, Bahlo J, Robrecht S, Tausch E, Bloehdorn J, Hoechstetter M, Fischer K, Eichhorst B, Goede V, Hallek M, Dohner H, Rosenquist R, Ghia P, Stamatopoulos K, Stilgenbauer S. Prognostic impact of prevalent chronic lymphocytic leukemia stereotyped subsets: analysis within prospective clinical trials of the German CLL Study Group (GCLLSG). Haematologica. 2020 Nov 1;105(11):2598-2607. doi: 10.3324/haematol.2019.231027.

    PubMed 33131249

  • Kreuzberger N, Damen JA, Trivella M, Estcourt LJ, Aldin A, Umlauff L, Vazquez-Montes MD, Wolff R, Moons KG, Monsef I, Foroutan F, Kreuzer KA, Skoetz N. Prognostic models for newly-diagnosed chronic lymphocytic leukaemia in adults: a systematic review and meta-analysis. Cochrane Database Syst Rev. 2020 Jul 31;7(7):CD012022. doi: 10.1002/14651858.CD012022.pub2.

    PubMed 32735048

  • Pflug N, Bahlo J, Shanafelt TD, Eichhorst BF, Bergmann MA, Elter T, Bauer K, Malchau G, Rabe KG, Stilgenbauer S, Dohner H, Jager U, Eckart MJ, Hopfinger G, Busch R, Fink AM, Wendtner CM, Fischer K, Kay NE, Hallek M. Development of a comprehensive prognostic index for patients with chronic lymphocytic leukemia. Blood. 2014 Jul 3;124(1):49-62. doi: 10.1182/blood-2014-02-556399. Epub 2014 May 5.

    PubMed 24797299

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fludarabine in people with Chronic Lymphocytic Leukemia, run by German CLL Study Group at 117 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 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 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 NCT00262782, which also lists 10 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 20 Feb 2020.

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