Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Bendamustine and Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over Other, Pharmaceutical / Industry GCLLSG-CLL2M EU-20552, EUDRACT-2005-001596-34, ROCHE-GCLLSG-CLL2M, NCT00274989

Objectives

Primary

1. Determine the overall response rate in patients with relapsed B-cell chronic lymphocytic leukemia treated with bendamustine and rituximab.

Secondary

1. Determine the overall response rate in biologically defined risk groups treated with this regimen.
2. Determine the duration of response, minimal residual disease response rate, and complete response rate in patients treated with this regimen.
3. Determine the event-free survival of patients treated with this regimen.
4. Determine the safety and toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) requiring treatment
  • Previously untreated Binet stage C or Binet B requiring treatment according to NCI criteria
  • Relapsed or refractory disease after treatment with ≥ 1 but no more than 3 prior regimens
    • Prior bendamustine allowed provided patient achieved at least a partial response that lasted at least 6 months AND completed treatment more than 6 months ago



• No progression to more aggressive B-cell cancers, such as Richter’s syndrome



• No known CNS involvement with B-CLL

Prior/Concurrent Therapy:

• See Disease Characteristics
• More than 3 weeks since prior anticancer therapy, major surgery, or irradiation
• Recovered from the acute side effects incurred as a result of previous therapy
• No use of investigational agents within 30 days prior to study
• No participation in another clinical trial

Patient Characteristics:

• WHO 0-2
• Life expectancy > 12 weeks
• Absolute neutrophil count ≥ 1,500/mm³, unless due to bone marrow involvement of CLL
• Platelet count ≥ 75,000/mm³, unless due to bone marrow involvement of CLL
• Creatinine ≤ 1.5 times upper limit of normal (ULN)

  OR

• Creatinine clearance > 30 mL/min
• Bilirubin, AST, and ALT ≤ 2 times ULN, unless directly attributable to the patient’s tumor
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for a minimum of 6 months after study therapy
• No history of anaphylaxis after exposure to monoclonal antibodies
• No known HIV
• No hepatitis B or C positivity
• No major organ malfunction (liver, kidney) that could interfere with the patient’s ability to participate in the study
• No active infection or history of severe infection (grade 4) within 3 months prior to study registration
• No medical condition requiring prolonged use of oral corticosteroids (> 1 month)
• No severe diabetes
• No active secondary malignancy
• No pulmonary disease (chronic obstructive pulmonary disease [COPD] with hypoxemia)
• No tuberculosis
• No New York Heart Association class III or IV heart disease
• No severe hypertension
• No other severe concurrent diseases
• No mental disorders
• No circumstance at the time of study entry that would preclude completion of the study or the required follow-up

Expected Enrollment

A total of 156 patients will be accrued for this study.

Outcomes

Overall response rate

Outline

This is an open-label, non-randomized, multicenter study.

Patients receive rituximab on day 0 in course 1 and on day 1 in courses 2-6. Patients also receive bendamustine on days 1 and 2 in courses 1-6. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

Trial Contact Information

Trial Lead Organizations

German CLL Study Group

Clemens Wendtner, Protocol chair		Ph: 49-221-4788-6720

Germany
	Arnstadt
	Internistische Praxis - Arnstadt
		Contact Person	Ph:  49-362-848-8171
			Email: dr.mueller.arnstadt@t-online.de
	Augsburg
	Klinikum Augsburg
		Contact Person	Ph:  49-821-400-2353
			Email: schlimok@klinikum-augsburd.de
	Bad Saarow
	Humaine - Clinic
		Contact Person	Ph:  49-336-317-3346
	Berlin
	Charite - Campus Charite Mitte
		Orhan Sezer, MD	Ph:  49-30-450-513105
			Email: sezer@charite.de
	Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
		V. Mansmann, MD	Ph:  49-30-8445-0
	Charite University Hospital - Campus Virchow Klinikum
		Stefanie Srock, MD	Ph:  49-30-450-553-192
			Email: stefanie.srock@charite.de
	Internistische Gemeinschaftspraxis - Berlin
		Contact Person	Ph:  49-30-455-0950
			Email: praxis@aerzteforum-seestrasse.de
	Bochum
	Augusta-Kranken-Anstalt gGmbH
		Contact Person	Ph:  49-234-517-2430
	Bottrop
	Marienhospital Bottrop gGmbH
		Contact Person	Ph:  49-204-1106-1000
			Email: eugen.musch@mhb-bottrop.de
	Bremen
	DIAKO Ev. Diakonie Krankenhaus gGmbH
		Karl-Heinz Pflueger, MD	Ph:  49-421-6102-1481
			Email: pfluegerkh@diako-bremen.de
	Cologne
	Medizinische Universitaetsklinik I at the University of Cologne
		Clemens Wendtner	Ph:  49-221-4788-6720
	Darmstadt
	Klinikum Darmstadt
		Contact Person	Ph:  49-6151-1070
	Dusseldorf
	Krankenhaus Benrath
		Contact Person	Ph:  49-211-977-1225
			Email: b.guenther@kliniken-duesseldorf.de
	Erfurt
	Helios Klinikum Erfurt
		Michael Herold, MD, PhD	Ph:  49-361-781-5205
	Essen
	Universitaetsklinikum Essen
		J. Duerig	Ph:  49-201-723-2321
	Esslingen
	Staedtische Kliniken Esslingen
		Robert Eckert, MD	Ph:  49-711-3103-2451
	Frankfurt (Oder)
	Klinikum Frankfurt (Oder) GmbH
		Michael Kiehl, MD, PhD	Ph:  49-335-548-4600
			Email: m.kiehl.km@klinikumffo.de
	Garmisch-Partenkirchen
	Klinikum Garmisch - Partenkirchen GmbH
		L. Schulz, MD	Ph:  49-8821-77-1520
			Email: lothar.schulz@klinikum-gap.de
	Germering
	Internistische Praxisgemeinschaft
		Contact Person	Ph:  49-89-842-910
			Email: jommitt@web.de
	Goettingen
	Universitaetsklinikum Goettingen
		L. Trumper	Ph:  49-551-398-600
	Greifswald
	Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
		C. Lotze, MD	Ph:  49-3834-866-700
	Hagen
	Allgemeines Krankenhaus Hagen
		Theo Scholten, MD	Ph:  49-23-31-201-2247
	Hamburg
	Asklepios Klinik St. Georg
		Maike Nickelsen, MD	Ph:  49-40-1818-854-234
	Hamatologische/Onkologische - Hamburg
		Contact Person	Ph:  49-403-802-1260
	Praxis fur Innere Medizin - Hamburg
		Contact Person	Ph:  49-40-593-5450
			Email: s.mueller-haggen@onkolgie-partner.de
	Hamm
	Evangelische Krankenhaus Hamm
		Leopold Balleisen, MD	Ph:  49-2381-589-1333
			Email: LBalleisen@evkhamm.de
	Homburg
	Universitaetsklinikum des Saarlandes
		Michael Pfreundschuh, MD	Ph:  49-6841-162-3084
			Email: michael.pfreundschuh@uniklinik-saarland.de
	Kaiserslautern
	Westpfalz-Klinikum GmbH
		Hartmut Link, MD, PhD	Ph:  49-631-203-1260
			Email: hlink@westpfalz-klinikum.de
	Karlsruhe
	Staedtisches Klinikum Karlsruhe gGmbH
		M. Schmier, MD	Ph:  49-721-974-0
	Kiel
	University Hospital Schleswig-Holstein - Kiel Campus
		Michael Kneba	Ph:  49-431-1697
	Leer
	Onkologische Schwerpunktpraxis - Leer
		Lothar Mueller, MD	Ph:  49-491-987-910
			Email: Lothar.Mueller@onkologie-leer.de
	Lemgo
	Klinikum Lippe - Lemgo
		F. Hartmann, MD	Ph:  49-5261-26-4122
			Email: frank.hartmann@klinikum-lippe.de
	Ludwigshafen
	Gemeinschaftspraxis - Ludwigshafen
		Contact Person	Ph:  49-621-562-817
			Email: khuenermund@hotmail.com
	Luedenscheid
	Kreiskrankenhaus Luedenscheid
		Gerhard Heil, MD	Ph:  49-235-1460
	Magdeburg
	Staedtisches Klinikum Magdeburg
		B. Bilsing, MD	Ph:  49-391-791-0
	Moenchengladbach
	Krankenhaus Maria Hilf GmbH
		Ullrich Graeven, MD, PhD	Ph:  49-2161-892-2201
			Email: inneren@mariahilf.de
	Muenster
	Haematologisch - Onkologische Gemeinschaftspraxis - Muenster
		Contact Person	Ph:  49-251-620-080
			Email: wehmeyer@onkologie-muenster.de
	Munich
	Klinikum der Universitaet Muenchen - Grosshadern Campus
		Wolfgang Hiddemann, MD, PhD	Ph:  49-89-7095-2551
	Neunkirchen
	Onkologische Schwerpunktpraxis Dr. Schmidt
		Contact Person	Ph:  49-682-1149-1111
			Email: praxis@onkologie-nk.de
	Oldenburg
	Klinikum Oldenburg
		Del Valle y Fuentes	Ph:  49-441-403-2611
	Ostfildern
	Paracelsus Karankenhaus Ruit
		Abele, MD	Ph:  49-7-114-4880
	Pinnebeg
	Gemeinschaftspraxis - Pinneberg
		Contact Person	Ph:  49-410-151-7930
	Potsdam
	Klinikum Ernst Von Bergmann
		F. Rothmann, MD	Ph:  49-331-241-6011
			Email: frothmann@klinikumevb.de
	Regensburg
	Klinikum der Universitaet Regensburg
		Stefan Krause, MD	Ph:  49-941-944-5538
	Krankenhaus Barmherzige Brueder Regensburg
		Contact Person	Ph:  49-941-369-2151
	Scherpunktpraxis fur Hematologie und Onkologie
		Contact Person	Ph:  49-941-566-342
			Email: info@onkologiepraxis-regensburg.de
	Rehling
	Internistische Praxis Dres. Hempel und Hochdorfer
		Contact Person	Ph:  49-823-795-9690
			Email: praxis@onkologie-rehlinge.de
	Rostock
	Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
		Contact Person	Ph:  49-381-494-7420
			Email: martin.soekler@med-uni-teubingen.de
	Saarbrucken
	Caritasklinik St. Theresia
		Axel Matzdorff, MD, PhD	Ph:  49-681-406-1101
	Siegburg
	Schwerpunktpraxis fur Hamatologie und Onkologie
		Contact Person	Ph:  49-224-159-540
			Email: info@onkopraxis-rhein-sieg.de
	Siegen
	St. Marien - Krankenhaus Siegen GMBH
		Contact Person	Ph:  49-271-231-1310
			Email: tobias.gaska@marienkrankenhaus.com
	Stralsund
	Hanse-Klinikum Stralsund - Krankenhaus West
		Ulrich Gerecke, MD	Ph:  49-3831-452-823
			Email: ulrich.gerecke@klinikum-hst.de
	Stuttgart
	Haematologische Praxis
		Gregor Springer, MD	Ph:  49-711-222-0244
	Trier
	Krankenanstalt Mutterhaus der Borromaerinnen
		Waladkhani, PhD	Ph:  49-651-947-2571
			Email: waladkhani@mutterhaus.de
	Tuebingen
	Universitaetsklinikum Tuebingen
		Sokler	Ph:  49-7071-298-2087
	Ulm
	Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
		Contact Person	Ph:  49-731-5004-5548
			Email: stephan.stilgenbauer@uniklinik-ulm.de
	Vechta
	St. Marienhospital - Vechta
		J. Diers, MD	Ph:  49-4441-99-0
	Zwickau
	Heinrich-Braun-Krankenhaus Zwickau
		Gabb, MD	Ph:  49-375-51-0

Registry Information
Official Title		Multicenter Phase II Trial of Bendamustine in Combination with Rituximab for Patients with Relapsed Chronic Lymphocytic Leukemia. CLL2M Protocol of the German CLL-Study Group (GCLLSG)
Trial Start Date		2005-11-01
Trial Completion Date		2008-03-31 (estimated)
Registered in ClinicalTrials.gov		NCT00274989
Date Submitted to PDQ		2005-09-30
Information Last Verified		2007-07-05

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