Bendamustine and Rituximab in Treating Patients With Previously Untreated or Relapsed Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Biological: Rituximab
- Registration Number
- NCT00274989
- Lead Sponsor
- German CLL Study Group
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
-
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
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bendamustine plus Rituximab Rituximab - Bendamustine plus Rituximab Bendamustine -
- Primary Outcome Measures
Name Time Method Overall response rate 56 days after the last of six cycles 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (58)
HELIOS Klinikum Bad Saarow
🇩🇪Bad Saarow, Germany
Internistische Praxis - Arnstadt
🇩🇪Arnstadt, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
University Hospital Schleswig-Holstein - Kiel Campus
🇩🇪Kiel, Germany
Staedtisches Klinikum Karlsruhe gGmbH
🇩🇪Karlsruhe, Germany
Onkologische Schwerpunktpraxis - Leer
🇩🇪Leer, Germany
Praxis fur Innere Medizin - Hamburg
🇩🇪Hamburg, Germany
Universitaetsklinikum des Saarlandes
🇩🇪Homburg, Germany
Evangelische Krankenhaus Hamm
🇩🇪Hamm, Germany
Gemeinschaftspraxis - Ludwigshafen
🇩🇪Ludwigshafen, Germany
Klinikum der Universitaet Regensburg
🇩🇪Regensburg, Germany
Westpfalz-Klinikum GmbH
🇩🇪Kaiserslautern, Germany
Haematologisch - Onkologische Gemeinschaftspraxis - Muenster
🇩🇪Muenster, Germany
Klinikum Ernst Von Bergmann
🇩🇪Potsdam, Germany
Kreiskrankenhaus Luedenscheid
🇩🇪Luedenscheid, Germany
Klinikum Lippe - Lemgo
🇩🇪Lemgo, Germany
Onkologische Schwerpunktpraxis Dr. Schmidt
🇩🇪Neunkirchen, Germany
Gemeinschaftspraxis - Pinneberg
🇩🇪Pinnebeg, Germany
Paracelsus Karankenhaus Ruit
🇩🇪Ostfildern, Germany
Staedtisches Klinikum Magdeburg
🇩🇪Magdeburg, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Krankenanstalt Mutterhaus der Borromaerinnen
🇩🇪Trier, Germany
St. Marienhospital - Vechta
🇩🇪Vechta, Germany
Schwerpunktpraxis fur Hamatologie und Onkologie
🇩🇪Siegburg, Germany
Scherpunktpraxis fur Hematologie und Onkologie
🇩🇪Regensburg, Germany
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
🇩🇪Rostock, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Krankenhaus Maria Hilf GmbH
🇩🇪Moenchengladbach, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
🇩🇪Munich, Germany
Klinikum Oldenburg
🇩🇪Oldenburg, Germany
St. Marien - Krankenhaus Siegen GMBH
🇩🇪Siegen, Germany
Heinrich-Braun-Krankenhaus Zwickau
🇩🇪Zwickau, Germany
Internistische Gemeinschaftspraxis - Berlin
🇩🇪Berlin, Germany
Charite - Campus Charite Mitte
🇩🇪Berlin, Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
🇩🇪Berlin, Germany
Charite University Hospital - Campus Virchow Klinikum
🇩🇪Berlin, Germany
Augusta-Kranken-Anstalt gGmbH
🇩🇪Bochum, Germany
Marienhospital Bottrop gGmbH
🇩🇪Bottrop, Germany
Medizinische Universitaetsklinik I at the University of Cologne
🇩🇪Cologne, Germany
Klinikum Darmstadt
🇩🇪Darmstadt, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
DIAKO Ev. Diakonie Krankenhaus gGmbH
🇩🇪Bremen, Germany
Krankenhaus Benrath
🇩🇪Dusseldorf, Germany
Helios Klinikum Erfurt
🇩🇪Erfurt, Germany
Staedtische Kliniken Esslingen
🇩🇪Esslingen, Germany
Universitaetsklinikum Goettingen
🇩🇪Goettingen, Germany
Klinikum Frankfurt (Oder) GmbH
🇩🇪Frankfurt (Oder), Germany
Internistische Praxisgemeinschaft
🇩🇪Germering, Germany
Hamatologische/Onkologische - Hamburg
🇩🇪Hamburg, Germany
Klinikum Garmisch - Partenkirchen GmbH
🇩🇪Garmisch-Partenkirchen, Germany
Allgemeines Krankenhaus Hagen
🇩🇪Hagen, Germany
Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
🇩🇪Greifswald, Germany
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
Krankenhaus Barmherzige Brueder Regensburg
🇩🇪Regensburg, Germany
Internistische Praxis Dres. Hempel und Hochdorfer
🇩🇪Rehling, Germany
Caritasklinik St. Theresia
🇩🇪Saarbrucken, Germany
Hanse-Klinikum Stralsund - Krankenhaus West
🇩🇪Stralsund, Germany
Haematologische Praxis
🇩🇪Stuttgart, Germany