Fludarabine and Darbepoetin Alfa in Treating Older Patients With Chronic Lymphocytic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00281892
First received: January 24, 2006
Last updated: August 23, 2013
Last verified: July 2007
  Purpose

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.


Condition Intervention Phase
Anemia
Leukemia
Biological: darbepoetin alfa
Drug: fludarabine phosphate
Phase 3

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Darbepoetin Alfa in Patients With Chronic Lymphocytic Leukemia and Comorbidity

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Efficacy [ Designated as safety issue: No ]
  • Anemia [ Designated as safety issue: No ]
  • Transfusion requirements [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Duration and frequency of hospitalization [ Designated as safety issue: No ]
  • Event-free survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Medical-economical impact [ Designated as safety issue: No ]

Estimated Enrollment: 348
Study Start Date: September 2004
Detailed Description:

OBJECTIVES:

  • Compare the efficacy of fludarabine with or without darbepoetin alfa in geriatric patients with chronic lymphocytic leukemia and relevant comorbidities.
  • Determine the effect of these regimens in reducing anemia, lowering the requirements of transfusion, and reducing the duration and frequency of hospitalization in these patients.
  • Determine the quality of life of patients treated with these regimens.
  • Determine event-free, progression-free, and overall survival of patients treated with these regimens.
  • Evaluate the medical-economical aspects of these regimens in these patients

OUTLINE: This is a multicenter study. Patients are stratified according to hemoglobin value (< 12 g/dL [stratum 1] vs > 12 g/dL [stratum 2]). Patients are assigned to 1 of 2 treatment strata.

  • Stratum 1: Patients receive fludarabine IV on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses. Patients also receive darbepoetin alfa subcutaneously once weekly for up to 6 weeks.
  • Stratum 2: Patients receive fludarabine as in stratum 1. Quality of life is evaluated periodically.

PROJECTED ACCRUAL: A total of 348 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic lymphocytic leukemia (CLL) meeting 1 of the following criteria:

    • Previously untreated disease
    • Progressive or relapsed CLL after treatment with nonpurine analog-containing regimens as chlorambucil or bendamustine hydrochloride
  • Meets 1 of the following staging criteria:

    • Binet stage A disease with B symptoms requiring treatment
    • Binet stage B disease requiring treatment, meeting ≥ 1 of the following criteria:

      • Rapid disease progression
      • Enlarged lymph nodes and organs
      • Severe B symptoms
    • Binet stage C disease
  • Must have comorbidities (i.e., CIRS score > 6)
  • Must have restricted kidney function (i.e., creatinine clearance < 70mL/min)
  • No transformation to aggressive non-Hodgkin's lymphoma (Richter's syndrome)

PATIENT CHARACTERISTICS:

  • Life expectancy > 6 months
  • Creatinine clearance > 30 mL/min
  • No active second malignancy
  • No active bacterial, viral, or fungal infection
  • No conditions that would preclude substitution of iron
  • No severe myocardial, coronary, or respiratory insufficiency
  • No severe liver insufficiency
  • No known hypersensitivity to darbepoetin alfa
  • No cerebral dysfunction that would preclude participation in the required study procedures

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent participation in another clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281892

Locations
Germany
Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg Recruiting
Augsburg, Germany, 86150
Contact: Contact Person    49-821-344-650      
Onkologische Schwerpunktpraxis und Tagesklinik Dres Recruiting
Bad Soden, Germany, 65812
Contact: Contact Person    49-619-665-7660    g.seipelt@telemed.de   
Charite - Campus Charite Mitte Recruiting
Berlin, Germany, D-10117
Contact: Contact Person    49-304-5051-3105    sezer@charite.de   
Internistische Gemeinschaftspraxis - Berlin Recruiting
Berlin, Germany, 13347
Contact: Contact Person    49-304-550-950    praxis@aerzteforum-seestrasse.de   
Augusta-Kranken-Anstalt gGmbH Recruiting
Bochum, Germany, D-44791
Contact: Contact Person    49-234-517-2430    d.behringer@augusta-bochum.de   
Medizinische Universitaetsklinik I at the University of Cologne Recruiting
Cologne, Germany, D-50924
Contact: Michael Hallek, MD    49-221-478-4400      
Internistische Praxis - Dusseldorf Recruiting
Dusseldorf, Germany, 40211
Contact: Contact Person    49-211-3677-7780    mlplingen.onkologie@gmx.de   
Hans - Susemihl - Krankenhaus Recruiting
Emden, Germany, D-26721
Contact: Contact Person    49-492-1981-295    h.becker@hsk-emden.de   
Universitaetsklinikum Essen Recruiting
Essen, Germany, D-45122
Contact: Contact Person    49-201-723-2417    ulrich.duehrsen@uk-essen.de   
Klinikum Frankfurt (Oder) GmbH Recruiting
Frankfurt (Oder), Germany, D-15236
Contact: Contact Person    49-335-548-4601    m.kiehl.km@klinikumffo.de   
Internistische Praxis - Gerlingen Recruiting
Gerlingen, Germany, 70839
Contact: Contact Person    49-715-622-240    schmitt-matti@telemed.de   
Internistische Praxisgemeinschaft Recruiting
Germering, Germany, 82110
Contact: Contact Person    49-89-842-910      
Universitaetsklinikum Goettingen Recruiting
Goettingen, Germany, D-37075
Contact: Contact Person    49-551-392-716    karo.hohloch@med.uni-goettingen.de   
Internistische Gemeinschaftspraxis - Halle Recruiting
Halle, Germany, 06110
Contact: Contact Person    49-345-682-360    rgrohrberg@onkologie-halle.de   
University Medical Center Hamburg - Eppendorf Recruiting
Hamburg, Germany, D-20246
Contact: Contact Person    49-404-2803-4253      
Clinic for Bone Marrow Transplantation and Hematology and Oncology Recruiting
Idar-Oberstein, Germany, D-55743
Contact: Contact Person    49-6781-1590    office@bmt-center-io-.com   
Westpfalz-Klinikum GmbH Recruiting
Kaiserslautern, Germany, D-67653
Contact: Contact Person    49-631-203-1872    hlink@westpfalz-klinikum.de   
Staedtisches Klinikum Karlsruhe gGmbH Recruiting
Karlsruhe, Germany, 76133
Contact: Contact Person    49-7821-974-3001    martin.bentz@klinikum-karlsruhe.com   
Klinikum Kempten Oberallgaeu Recruiting
Kempten, Germany, D-87439
Contact: Contact Person    49-831-530-2226    otto.pruemmer@klinikum-kempten.de   
Internistische Onkologische Praxis - Kronach Recruiting
Kronach, Germany, 96317
Contact: Contact Person    49-926-162-480    praxisdrstauch@t-online.de   
Internistische Praxis - Landshut Recruiting
Landshut, Germany, 84028
Contact: Contact Person    49-871-275-381      
Caritas - Krakenhaus Lebach Recruiting
Lebach, Germany, 66822
Contact: Contact Person    49-688-150-1217    s.kremers@caritas-krankenhaus-lebach.de   
Onkologische Schwerpunktpraxis - Leer Recruiting
Leer, Germany, D-26789
Contact: Contact Person    49-491-987-910    lothar.mueller@onkologie-leer.de   
Staedtisches Klinikum Magdeburg Recruiting
Magdeburg, Germany, D-39130
Contact: Contact Person    49-688-150-1217    erika.kettner@klinikum-magdeburg.de   
Hospital Maria-Hilf II Recruiting
Monchengladbach, Germany, D-41063
Contact: Contact Person    49-2161-8920    klingelr@mariahilf.de   
Hamatologie/Onkologie Praxisgemeinschaft - Muenchen Recruiting
Munchen, Germany, 81245
Contact: Contact Person         
Klinikum der Universitaet Muenchen - Grosshadern Campus Recruiting
Munich, Germany, D-81377
Contact: Contact Person    49-89-7095-2551      
Haematologische Schwerpunktpraxis Recruiting
Munich, Germany, D-81679
Contact: Contact Person    49-899-972-0272    helmut.htz@web.de   
I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen Recruiting
Munich, Germany, D-81377
Contact: Contact Person    49-897-095-4230    manuela.bergmann@med.uni-muenchen.de   
Munich Oncologic Practice at Elisenhof Recruiting
Munich, Germany, D-80335
Contact: Contact Person    49-895-5191    abenhardt@t-online.de   
Klinikum Schwaebisch Gmuend Stauferklinik Recruiting
Mutlangen, Germany, D-73557
Contact: Contact Person    49-717-1701-1302    holger.hebart@klinikum-sgd.de   
Onkologische Schwerpunktpraxis Dr. Schmidt Recruiting
Neunkirchen, Germany, D-66538
Contact: Contact Person    49-682-1149-1111    praxis@onkologie-nk.de   
Praxis fuer Haematologie und Interne Onkologie Recruiting
Norderstedt, Germany, 22844
Contact: Contact Person    49-40-526-5060    dr.r.hoffmann.norderstedt@t-online.de   
Internistische Gemeinschaftspraxis - Oldenburg Recruiting
Oldenburg, Germany, D-26121
Contact: Contact Person    49-441-772-5980      
Recruiting
Pforzheim, Germany, 75179
Contact: Yves Dencausse, MD    49-7231-280-3780      
Krankenhaus Barmherzige Brueder Regensburg Recruiting
Regensburg, Germany, D-93049
Contact: Contact Person    49-941-369-2151      
Scherpunktpraxis fur Hematologie und Onkologie Recruiting
Regensburg, Germany, 93053
Contact: Contact Person    49-941-566-342    info@onkologiepraxis-regensburg.de   
Schwerpunktpraxis fuer Haematologie und Onkologie Recruiting
Saarbruecken, Germany, 66113
Contact: Contact Person    49-681-473-575      
St. Marien - Krankenhaus Siegen GMBH Recruiting
Siegen, Germany, D-57072
Contact: Contact Person    49-271-231-1310      
Southwest German Cancer Center at Eberhard-Karls-University Recruiting
Tuebingen, Germany, D-72076
Contact: Contact Person    49-7071-292-711      
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm Recruiting
Ulm, Germany, D-89081
Contact: Contact Person    49-731-502-4400      
St. Marienhospital - Vechta Recruiting
Vechta, Germany, D-49377
Contact: Contact Person    49-4441-99-0      
Haematologische Praxis Recruiting
Weiden, Germany, D-92637
Contact: Contact Person    49-9613-2060    j.b.weiss@gmx.de   
Helios Kliniken Wuppertal University Hospital Recruiting
Wuppertal, Germany, D-42283
Contact: Contact Person    49-896-3351    michael.may@helios-kliniken.de   
Hamatologisch - Onkologische Praxis Wurzburg Recruiting
Wurzburg, Germany, 97070
Contact: Contact Person    49-931-322-670      
Sponsors and Collaborators
German CLL Study Group
Investigators
Study Chair: Michael Hallek, MD Medizinische Universitaetsklinik I at the University of Cologne
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00281892     History of Changes
Other Study ID Numbers: CDR0000454570, GCLLSG-CLL9, EU-20561, AMGEN-GCLLSG-CLL9, EUDRACT-2005-003014-15
Study First Received: January 24, 2006
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
anemia
refractory chronic lymphocytic leukemia
stage 0 chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia

Additional relevant MeSH terms:
Anemia
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Hematologic Diseases
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine
Fludarabine monophosphate
Vidarabine
Darbepoetin alfa
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on July 20, 2014