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Chronic Lymphocytic LeukemiaPhase 2NCT00274989

Bendamustine and Rituximab in Treating Patients With Previously Untreated or Relapsed Chronic Lymphocytic Leukemia

A Phase 2 study testing Bendamustine and Rituximab in people with Chronic Lymphocytic Leukemia, run by German CLL Study Group at 58 sites in Germany.

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

CLL2M is a phase 2, multicenter, open label study to investigate the possible therapeutic benefits of using bendamustine in combination with rituximab for the treatment of patients with previously untreated or relapsed CLL. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Bendamustine and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
195 participants
Where
58 sitesGermany
Study dates
Nov 2005to Mar 2011
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Diagnosis of B-CLL in need of treatment
  • Previously untreated Binet stage C or Binet B with need of treatment according to NCI-criteria
  • Relapsed or refractory disease after at least one but not more than 3 prior regimens. Patients who previously received bendamustine must have had at least a partial response with duration of response of at least six months.
  • World Health Organization performance status of 0-2
  • Life expectancy >12 weeks
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  • Anti-cancer therapy, major surgery, or irradiation was completed >3 weeks before registration in this study. Patient must have recovered from the acute side effects incurred as a result of previous therapy.
  • Serum creatinine ≤1.5 the institutional upper limit of normal (ULN) or Creatinine clearance >30 ml/min/1.73 m²
  • Adequate liver function as indicated by a total bilirubin, AST, and ALT ≤2 the institutional ULN value, unless directly attributable to the patient's tumor.
  • Female patients with childbearing potential must have a negative serum pregnancy test within two weeks of first dose of study drug(s). Male and female patients must agree to use an effective contraceptive method while on study treatment and for a minimum of six months following study therapy.
  • Signed, written informed consent.

Who cannot join

  • Previously treated with >3 prior regimens for B-CLL.
  • Known central nervous system (CNS) involvement with B-CLL.
  • Patients who have progressed with more aggressive B-cell cancers such as Richter's syndrome.
  • History of anaphylaxis following exposure to monoclonal antibodies.
  • Known to be human immunodeficiency virus (HIV), hepatitis B, or C positive.
  • Active infection or history of severe infection (grade 4) within 3 months prior to study registration.
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  • Medical condition requiring prolonged use of oral corticosteroids (> 1 month).
  • Use of investigational agents within 30 days prior to study randomization.
  • Active secondary malignancy.
  • ANC <1.5x109/L or platelet count <75x109/L, unless due to bone marrow involvement of CLL.
  • Other severe, concurrent diseases, including tuberculosis, mental disorders, serious cardiac functional capacity (Class III or IV as defined by the New York Heart Association Classification), severe diabetes, severe hypertension, pulmonary disease (chronic obstructive pulmonary disease [COPD] with hypoxemia), or major organ malfunction (liver, kidney) that could interfere with the patient's ability to participate in the study.
  • Pregnant or nursing women.
  • Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.
  • Participation in another clinical trial

Trial locations and contacts

58 sites in 1 country.

58 sites in 1 country

Germany58 sites

  • Internistische Praxis - Arnstadt

    Arnstadt, 99310

  • Klinikum Augsburg

    Augsburg, D-86156

  • HELIOS Klinikum Bad Saarow

    Bad Saarow, 15526

  • Internistische Gemeinschaftspraxis - Berlin

    Berlin, 13347

  • Charite - Campus Charite Mitte

    Berlin, D-10117

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, D-12200

  • Charite University Hospital - Campus Virchow Klinikum

    Berlin, D-13353

  • Augusta-Kranken-Anstalt gGmbH

    Bochum, D-44791

  • Marienhospital Bottrop gGmbH

    Bottrop, D-46236

  • DIAKO Ev. Diakonie Krankenhaus gGmbH

    Bremen, D-28239

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, D-50924

  • Klinikum Darmstadt

    Darmstadt, D-64283

  • Krankenhaus Benrath

    Düsseldorf, 40593

  • Helios Klinikum Erfurt

    Erfurt, 99012

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Staedtische Kliniken Esslingen

    Esslingen am Neckar, D-73730

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), D-15236

  • Klinikum Garmisch - Partenkirchen GmbH

    Garmisch-Partenkirchen, D-82467

  • Internistische Praxisgemeinschaft

    Germering, 82110

  • Universitaetsklinikum Goettingen

    Göttingen, D-37075

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

    Greifswald, D-17475

  • Allgemeines Krankenhaus Hagen

    Hagen, D-58095

  • Praxis fur Innere Medizin - Hamburg

    Hamburg, 22457

  • Hamatologische/Onkologische - Hamburg

    Hamburg, 22767

  • Asklepios Klinik St. Georg

    Hamburg, D-20099

  • Evangelische Krankenhaus Hamm

    Hamm, DOH-59063

  • Universitaetsklinikum des Saarlandes

    Homburg, D-66424

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, D-67653

  • Staedtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

  • University Hospital Schleswig-Holstein - Kiel Campus

    Kiel, D-24116

  • Onkologische Schwerpunktpraxis - Leer

    Leer, D-26789

  • Klinikum Lippe - Lemgo

    Lemgo, D-32657

  • Kreiskrankenhaus Luedenscheid

    Lüdenscheid, 58515

  • Gemeinschaftspraxis - Ludwigshafen

    Ludwigshafen, 67061

  • Staedtisches Klinikum Magdeburg

    Magdeburg, D-39130

  • Krankenhaus Maria Hilf GmbH

    Mönchengladbach, D-41063

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Haematologisch - Onkologische Gemeinschaftspraxis - Muenster

    Münster, D-48149

  • Onkologische Schwerpunktpraxis Dr. Schmidt

    Neunkirchen, D-66538

  • Klinikum Oldenburg

    Oldenburg, D-26133

  • Paracelsus Karankenhaus Ruit

    Ostfildern, 73760

  • Gemeinschaftspraxis - Pinneberg

    Pinnebeg, 25421

  • Klinikum Ernst Von Bergmann

    Potsdam, D-14467

  • Scherpunktpraxis fur Hematologie und Onkologie

    Regensburg, 93053

  • Klinikum der Universitaet Regensburg

    Regensburg, D-93042

  • Krankenhaus Barmherzige Brueder Regensburg

    Regensburg, D-93049

  • Internistische Praxis Dres. Hempel und Hochdorfer

    Rehling, 86508

  • Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

    Rostock, D-18057

  • Caritasklinik St. Theresia

    Saarbrücken, D-66113

  • Schwerpunktpraxis fur Hamatologie und Onkologie

    Siegburg, 53721

  • St. Marien - Krankenhaus Siegen GMBH

    Siegen, D-57072

  • Hanse-Klinikum Stralsund - Krankenhaus West

    Stralsund, D-18437

  • Haematologische Praxis

    Stuttgart, D-70173

  • Krankenanstalt Mutterhaus der Borromaerinnen

    Trier, D-54290

  • Universitaetsklinikum Tuebingen

    Tübingen, D-72076

  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

    Ulm, D-89081

  • St. Marienhospital - Vechta

    Vechta, D-49377

  • Heinrich-Braun-Krankenhaus Zwickau

    Zwickau, 08060

Other trials in Germany

About this study

Official title: Multicentre Phase II Trial of Bendamustine in Combination With Rituximab for Patients With Previously Untreated or Relapsed Chronic Lymphocytic Leukemia. CLL2M Protocol of the German CLL-Study Group (GCLLSG)

CLL2M is a phase 2, multicenter, open label study to investigate the possible therapeutic benefits of using bendamustine in combination with rituximab for the treatment of patients with previously untreated or relapsed CLL.

Read the detailed description

Conventional chemotherapy and also high dose chemotherapy with autologous stem cell transplantation are not curative treatment options in B-CLL; nearly all patients will eventually relapse. Also monoclonal antibodies are not curative for B-CLL patients in monotherapy, their impact on survival in combination with conventional chemotherapy is currently validated. In addition, there is no standard combination therapy for patients with relapsed CLL. Therefore there is an urgent medical need to identify new strategies.

The combination of rituximab (monoclonal antibody) and bendamustine (chemotherapy) has shown encouraging activity in patients with relapsed/refractory NHL or mantle cell lymphoma. In vitro studies have been used to investigate the effects of bendamustine and rituximab on programmed cell death (apoptosis) and have shown synergistic effects of both drugs. The mechanisms of action of these two active drugs may provide a treatment with good therapeutic potential in CLL. However, though bendamustine has been used for over 30 years there is still a need to define a standard regimen for the use of bendamustine in combination with monoclonal antibodies (mAb) especially in the treatment of CLL.

Being tested
Bendamustine, Rituximab
Keywords
B-cell chronic lymphocytic leukemia, relapsed refractory chronic lymphocytic leukemia, previously untreated 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.

  • BendamustineDrug

    First-Line Therapy: Bendamustine i.v. 90 mg/m² day 1-2, q4wks, cycle 1 to 6

    2nd to 4th -Line Therapy: Bendamustine i.v. 70 mg/m² day 1-2 q4wks, cycle 1 to 6

  • RituximabBiological

    Also called MabThera, Rituxan

    First-Line Therapy: Rituximab i.v. 375 mg/m² day 0, q4wks, cycle 1; Rituximab i.v. 500 mg/m² day 1, q4wks, cycle 2-6

    2nd to 4th -Line Therapy: Rituximab i.v. 375 mg/m² day 0, q4wks, cycle 1; Rituximab i.v. 500 mg/m² day 1, q4wks, cycle 2-6

Study groups in NCT00274989
Study groupRoleWhat they receive
Bendamustine plus RituximabExperimentalNot described
Receives: Drug: Bendamustine; Biological: Rituximab

What is being measured

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

  1. Overall response rate

    Response will be assessed using clinical examination, hematology, bone marrow examination, plain radiograph of the chest (chest X-ray), ultrasound or CT of the abdomen, and MRD testing (for the molecular response rate only).

    Measured: 56 days after the last of six cycles

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 startNov 2005
  3. Primary completionMar 2008
  4. Study completionMar 2011

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00274989
Sponsor's protocol ID
CLL2M
Other IDs
EU-20552, ROCHE-GCLLSG-CLL2M, 2005-001596-34, 2005
Status last verified
May 2019
First submitted
10 Jan 2006
Last updated
23 May 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Al-Sawaf O, Robrecht S, Bahlo J, Fink AM, Cramer P, von Tresckow J, Maurer C, Bergmann M, Seiler T, Lange E, Kneba M, Stilgenbauer S, Dohner H, Kiehl MG, Jager U, Wendtner CM, Fischer K, Goede V, Hallek M, Eichhorst B, Hopfinger G. Impact of gender on outcome after chemoimmunotherapy in patients with chronic lymphocytic leukemia: a meta-analysis by the German CLL study group. Leukemia. 2017 Oct;31(10):2251-2253. doi: 10.1038/leu.2017.221. Epub 2017 Jul 12. No abstract available.

    PubMed 28745332

  • 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

  • Fischer K, Cramer P, Busch R, Stilgenbauer S, Bahlo J, Schweighofer CD, Bottcher S, Staib P, Kiehl M, Eckart MJ, Kranz G, Goede V, Elter T, Buhler A, Winkler D, Kneba M, Dohner H, Eichhorst BF, Hallek M, Wendtner CM. Bendamustine combined with rituximab in patients with relapsed and/or refractory chronic lymphocytic leukemia: a multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2011 Sep 10;29(26):3559-66. doi: 10.1200/JCO.2010.33.8061. Epub 2011 Aug 15.

    PubMed 21844497

  • Fischer K, Cramer P, Busch R, Bottcher S, Bahlo J, Schubert J, Pfluger KH, Schott S, Goede V, Isfort S, von Tresckow J, Fink AM, Buhler A, Winkler D, Kreuzer KA, Staib P, Ritgen M, Kneba M, Dohner H, Eichhorst BF, Hallek M, Stilgenbauer S, Wendtner CM. Bendamustine in combination with rituximab for previously untreated patients with chronic lymphocytic leukemia: a multicenter phase II trial of the German Chronic Lymphocytic Leukemia Study Group. J Clin Oncol. 2012 Sep 10;30(26):3209-16. doi: 10.1200/JCO.2011.39.2688. Epub 2012 Aug 6.

    PubMed 22869884

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bendamustine and Rituximab in people with Chronic Lymphocytic Leukemia, run by German CLL Study Group at 58 sites in Germany.

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

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. 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 58 sites in Germany. 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?

Overall response rate (time frame: 56 days after the last of six cycles). 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 NCT00274989, 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 23 May 2019.

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