Bendamustine and Rituximab in Treating Patients With Previously Untreated or Relapsed Chronic Lymphocytic Leukemia
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)
4 other identifiers
interventional
195
1 country
58
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2005
Longer than P75 for phase_2
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 10, 2006
CompletedFirst Posted
Study publicly available on registry
January 11, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedMay 23, 2019
May 1, 2019
2.3 years
January 10, 2006
May 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
56 days after the last of six cycles
Study Arms (1)
Bendamustine plus Rituximab
EXPERIMENTALInterventions
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
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
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- German CLL Study Grouplead
- University of Colognecollaborator
Study Sites (58)
Internistische Praxis - Arnstadt
Arnstadt, 99310, Germany
Klinikum Augsburg
Augsburg, D-86156, Germany
HELIOS Klinikum Bad Saarow
Bad Saarow, 15526, Germany
Internistische Gemeinschaftspraxis - Berlin
Berlin, 13347, Germany
Charite - Campus Charite Mitte
Berlin, D-10117, Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, D-12200, Germany
Charite University Hospital - Campus Virchow Klinikum
Berlin, D-13353, Germany
Augusta-Kranken-Anstalt gGmbH
Bochum, D-44791, Germany
Marienhospital Bottrop gGmbH
Bottrop, D-46236, Germany
DIAKO Ev. Diakonie Krankenhaus gGmbH
Bremen, D-28239, Germany
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, D-50924, Germany
Klinikum Darmstadt
Darmstadt, D-64283, Germany
Krankenhaus Benrath
Düsseldorf, 40593, Germany
Helios Klinikum Erfurt
Erfurt, 99012, Germany
Universitaetsklinikum Essen
Essen, D-45122, Germany
Staedtische Kliniken Esslingen
Esslingen am Neckar, D-73730, Germany
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), D-15236, Germany
Klinikum Garmisch - Partenkirchen GmbH
Garmisch-Partenkirchen, D-82467, Germany
Internistische Praxisgemeinschaft
Germering, 82110, Germany
Universitaetsklinikum Goettingen
Göttingen, D-37075, Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, D-17475, Germany
Allgemeines Krankenhaus Hagen
Hagen, D-58095, Germany
Praxis fur Innere Medizin - Hamburg
Hamburg, 22457, Germany
Hamatologische/Onkologische - Hamburg
Hamburg, 22767, Germany
Asklepios Klinik St. Georg
Hamburg, D-20099, Germany
Evangelische Krankenhaus Hamm
Hamm, DOH-59063, Germany
Universitaetsklinikum des Saarlandes
Homburg, D-66424, Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, D-67653, Germany
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, 76133, Germany
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, D-24116, Germany
Onkologische Schwerpunktpraxis - Leer
Leer, D-26789, Germany
Klinikum Lippe - Lemgo
Lemgo, D-32657, Germany
Gemeinschaftspraxis - Ludwigshafen
Ludwigshafen, 67061, Germany
Kreiskrankenhaus Luedenscheid
Lüdenscheid, 58515, Germany
Staedtisches Klinikum Magdeburg
Magdeburg, D-39130, Germany
Krankenhaus Maria Hilf GmbH
Mönchengladbach, D-41063, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, D-81377, Germany
Haematologisch - Onkologische Gemeinschaftspraxis - Muenster
Münster, D-48149, Germany
Onkologische Schwerpunktpraxis Dr. Schmidt
Neunkirchen, D-66538, Germany
Klinikum Oldenburg
Oldenburg, D-26133, Germany
Paracelsus Karankenhaus Ruit
Ostfildern, 73760, Germany
Gemeinschaftspraxis - Pinneberg
Pinnebeg, 25421, Germany
Klinikum Ernst Von Bergmann
Potsdam, D-14467, Germany
Scherpunktpraxis fur Hematologie und Onkologie
Regensburg, 93053, Germany
Klinikum der Universitaet Regensburg
Regensburg, D-93042, Germany
Krankenhaus Barmherzige Brueder Regensburg
Regensburg, D-93049, Germany
Internistische Praxis Dres. Hempel und Hochdorfer
Rehling, 86508, Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
Rostock, D-18057, Germany
Caritasklinik St. Theresia
Saarbrücken, D-66113, Germany
Schwerpunktpraxis fur Hamatologie und Onkologie
Siegburg, 53721, Germany
St. Marien - Krankenhaus Siegen GMBH
Siegen, D-57072, Germany
Hanse-Klinikum Stralsund - Krankenhaus West
Stralsund, D-18437, Germany
Haematologische Praxis
Stuttgart, D-70173, Germany
Krankenanstalt Mutterhaus der Borromaerinnen
Trier, D-54290, Germany
Universitaetsklinikum Tuebingen
Tübingen, D-72076, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, D-89081, Germany
St. Marienhospital - Vechta
Vechta, D-49377, Germany
Heinrich-Braun-Krankenhaus Zwickau
Zwickau, 08060, Germany
Related Publications (4)
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.
PMID: 28745332BACKGROUNDSachanas 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.
PMID: 31092457BACKGROUNDFischer 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.
PMID: 21844497RESULTFischer 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.
PMID: 22869884RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clemens M. Wendtner
Medizinische Universitaetsklinik I at the University of Cologne
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2006
First Posted
January 11, 2006
Study Start
November 1, 2005
Primary Completion
March 1, 2008
Study Completion
March 1, 2011
Last Updated
May 23, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share