Fludarabine and Darbepoetin Alfa in Treating Older Patients With Chronic Lymphocytic Leukemia
Darbepoetin Alfa in Patients With Chronic Lymphocytic Leukemia and Comorbidity
5 other identifiers
interventional
97
1 country
46
Brief 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. Darbepoetin alfa may cause the body to make more red blood cells. It is not yet known whether fludarabine is more effective with or without darbepoetin alfa in treating chronic lymphocytic leukemia. PURPOSE: This phase III trial is studying fludarabine to see how well it works when given together with or without darbepoetin alfa in treating older patients with chronic lymphocytic leukemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2004
Longer than P75 for phase_3
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 24, 2006
CompletedFirst Posted
Study publicly available on registry
January 25, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedMay 11, 2018
May 1, 2018
3.7 years
January 24, 2006
May 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event-free survival
defined as the time from initial randomization/stratification to the time-point of progressive disease, new therapy, or death)
up to 24 months after the last dose of study medication
Secondary Outcomes (2)
Response Rate
2 months after the end of the last cycle
toxicity
28 days after the end of the last cycle
Study Arms (2)
Fludarabine plus Darbopoetin
EXPERIMENTALGroup 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles and 500 mcg of darbepoetin alfa subcutaneously every 3 weeks
fludarabine mono
ACTIVE COMPARATORGroup 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles with no additional growth factor support. Group 2 - Patients with an initial Hb-value more than 12 g/dl start to receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles . Patients of group 2 will be eventually randomized at later timepoints, if the Hb-value drops below 12 g/dl. Randomized patients will receive either 500 mcg darbepoetin alfa subcutaneously every 3 weeks or continue therapy with fludarabine without additional administration of darbepoetin alfa.
Interventions
Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles and 500 mcg of darbepoetin alfa subcutaneously every 3 weeks
Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles with no additional growth factor support. Group 2 - Patients with an initial Hb-value more than 12 g/dl start to receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles . Patients of group 2 will be eventually randomized at later timepoints, if the Hb-value drops below 12 g/dl. Randomized patients will receive either 500 mcg darbepoetin alfa subcutaneously every 3 weeks or continue therapy with fludarabine without additional administration of darbepoetin alfa.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (46)
Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
Augsburg, 86150, Germany
Onkologische Schwerpunktpraxis und Tagesklinik Dres
Bad Soden, 65812, Germany
Internistische Gemeinschaftspraxis - Berlin
Berlin, 13347, Germany
Charite - Campus Charite Mitte
Berlin, D-10117, Germany
Augusta-Kranken-Anstalt gGmbH
Bochum, D-44791, Germany
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, D-50924, Germany
Internistische Praxis - Dusseldorf
Düsseldorf, 40211, Germany
Hans - Susemihl - Krankenhaus
Emden, D-26721, Germany
Universitaetsklinikum Essen
Essen, D-45122, Germany
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), D-15236, Germany
Internistische Praxis - Gerlingen
Gerlingen, 70839, Germany
Internistische Praxisgemeinschaft
Germering, 82110, Germany
Universitaetsklinikum Göttingen
Göttingen, 37075, Germany
Internistische Gemeinschaftspraxis - Halle
Halle, 06110, Germany
University Medical Center Hamburg - Eppendorf
Hamburg, D-20246, Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology
Idar-Oberstein, D-55743, Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, D-67653, Germany
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, 76133, Germany
Klinikum Kempten Oberallgaeu
Kempten, D-87439, Germany
Internistische Onkologische Praxis - Kronach
Kronach, 96317, Germany
Internistische Praxis - Landshut
Landshut, 84028, Germany
Caritas - Krakenhaus Lebach
Lebach, 66822, Germany
Onkologische Schwerpunktpraxis - Leer
Leer, D-26789, Germany
Staedtisches Klinikum Magdeburg
Magdeburg, D-39130, Germany
Hospital Maria-Hilf II
Mönchengladbach, D-41063, Germany
Munich Oncologic Practice at Elisenhof
Munich, D-80335, Germany
I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
Munich, D-81377, Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, D-81377, Germany
Haematologische Schwerpunktpraxis
Munich, D-81679, Germany
Klinikum Schwaebisch Gmuend Stauferklinik
Mutlangen, D-73557, Germany
Hamatologie/Onkologie Praxisgemeinschaft - Muenchen
München, 81245, Germany
Haematologische-onkologische GemeinschaftspraxisSchick - Schick - Schmidt - Wiesmeier
München, D-81241, Germany
Onkologische Schwerpunktpraxis Dr. Schmidt
Neunkirchen, D-66538, Germany
Praxis fuer Haematologie und Interne Onkologie
Norderstedt, 22844, Germany
Internistische Gemeinschaftspraxis - Oldenburg
Oldenburg, D-26121, Germany
Unknown Facility
Pforzheim, 75179, Germany
Scherpunktpraxis fur Hematologie und Onkologie
Regensburg, 93053, Germany
Krankenhaus Barmherzige Brueder Regensburg
Regensburg, D-93049, Germany
Schwerpunktpraxis fuer Haematologie und Onkologie
Saarbrücken, 66113, Germany
St. Marien - Krankenhaus Siegen GMBH
Siegen, D-57072, Germany
Southwest German Cancer Center at Eberhard-Karls-University
Tübingen, D-72076, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, D-89081, Germany
St. Marienhospital - Vechta
Vechta, D-49377, Germany
Haematologische Praxis
Weiden, D-92637, Germany
Helios Kliniken Wuppertal University Hospital
Wuppertal, D-42283, Germany
Hamatologisch - Onkologische Praxis Wurzburg
Würzburg, 97070, Germany
Related Publications (2)
Goede V, Busch R, Bahlo J, Chataline V, Kremers S, Muller L, Reschke D, Schlag R, Schmidt B, Vehling-Kaiser U, Wedding U, Stilgenbauer S, Hallek M. Low-dose fludarabine with or without darbepoetin alfa in patients with chronic lymphocytic leukemia and comorbidity: primary results of the CLL9 trial of the German CLL Study Group. Leuk Lymphoma. 2016;57(3):596-603. doi: 10.3109/10428194.2015.1079314. Epub 2015 Oct 12.
PMID: 26293380RESULTGoede V, Bahlo J, Chataline V, Eichhorst B, Durig J, Stilgenbauer S, Kolb G, Honecker F, Wedding U, Hallek M. Evaluation of geriatric assessment in patients with chronic lymphocytic leukemia: Results of the CLL9 trial of the German CLL study group. Leuk Lymphoma. 2016;57(4):789-96. doi: 10.3109/10428194.2015.1091933. Epub 2015 Oct 13.
PMID: 26377031RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Hallek, MD
Medizinische Universitaetsklinik I at the University of Cologne
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2006
First Posted
January 25, 2006
Study Start
September 1, 2004
Primary Completion
May 1, 2008
Study Completion
October 1, 2010
Last Updated
May 11, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share