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Chronic Lymphocytic LeukemiaPhase 3NCT00281892

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

A Phase 3 study testing Fludarabine plus Darbopoetin and Fludarabine mono in people with Chronic Lymphocytic Leukemia and Anemia, run by German CLL Study Group at 46 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Chronic Lymphocytic Leukemia, Anemia
What is being tested?
Fludarabine plus Darbopoetin and Fludarabine mono
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
46 sitesGermany
Study dates
Sep 2004to Oct 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

Germany46 sites

  • Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg

    Augsburg, 86150

  • Onkologische Schwerpunktpraxis und Tagesklinik Dres

    Bad Soden, 65812

  • Internistische Gemeinschaftspraxis - Berlin

    Berlin, 13347

  • Charite - Campus Charite Mitte

    Berlin, D-10117

  • Augusta-Kranken-Anstalt gGmbH

    Bochum, D-44791

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, D-50924

  • Internistische Praxis - Dusseldorf

    Düsseldorf, 40211

  • Hans - Susemihl - Krankenhaus

    Emden, D-26721

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), D-15236

  • Internistische Praxis - Gerlingen

    Gerlingen, 70839

  • Internistische Praxisgemeinschaft

    Germering, 82110

  • Universitaetsklinikum Göttingen

    Göttingen, 37075

  • Internistische Gemeinschaftspraxis - Halle

    Halle, 06110

  • University Medical Center Hamburg - Eppendorf

    Hamburg, D-20246

  • Clinic for Bone Marrow Transplantation and Hematology and Oncology

    Idar-Oberstein, D-55743

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, D-67653

  • Staedtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

  • Klinikum Kempten Oberallgaeu

    Kempten, D-87439

  • Internistische Onkologische Praxis - Kronach

    Kronach, 96317

  • Internistische Praxis - Landshut

    Landshut, 84028

  • Caritas - Krakenhaus Lebach

    Lebach, 66822

  • Onkologische Schwerpunktpraxis - Leer

    Leer, D-26789

  • Staedtisches Klinikum Magdeburg

    Magdeburg, D-39130

  • Hospital Maria-Hilf II

    Mönchengladbach, D-41063

  • Hamatologie/Onkologie Praxisgemeinschaft - Muenchen

    München, 81245

  • Haematologische-onkologische GemeinschaftspraxisSchick - Schick - Schmidt - Wiesmeier

    München, D-81241

  • Munich Oncologic Practice at Elisenhof

    Munich, D-80335

  • I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen

    Munich, D-81377

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Haematologische Schwerpunktpraxis

    Munich, D-81679

  • Klinikum Schwaebisch Gmuend Stauferklinik

    Mutlangen, D-73557

  • Onkologische Schwerpunktpraxis Dr. Schmidt

    Neunkirchen, D-66538

  • Praxis fuer Haematologie und Interne Onkologie

    Norderstedt, 22844

  • Internistische Gemeinschaftspraxis - Oldenburg

    Oldenburg, D-26121

  • Study site

    Pforzheim, 75179

  • Scherpunktpraxis fur Hematologie und Onkologie

    Regensburg, 93053

  • Krankenhaus Barmherzige Brueder Regensburg

    Regensburg, D-93049

  • Schwerpunktpraxis fuer Haematologie und Onkologie

    Saarbrücken, 66113

  • St. Marien - Krankenhaus Siegen GMBH

    Siegen, D-57072

  • Southwest German Cancer Center at Eberhard-Karls-University

    Tübingen, D-72076

  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

    Ulm, D-89081

  • St. Marienhospital - Vechta

    Vechta, D-49377

  • Haematologische Praxis

    Weiden, D-92637

  • Helios Kliniken Wuppertal University Hospital

    Wuppertal, D-42283

  • Hamatologisch - Onkologische Praxis Wurzburg

    Würzburg, 97070

Other trials in Germany

About this study

Official title: Darbepoetin Alfa in Patients With Chronic Lymphocytic Leukemia and Comorbidity

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.

Read the 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.

Being tested
Fludarabine plus Darbopoetin, Fludarabine mono
Keywords
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
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fludarabine plus DarbopoetinBiological

    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

  • Fludarabine monoDrug

    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.

Study groups in NCT00281892
Study groupRoleWhat they receive
Fludarabine plus DarbopoetinExperimentalGroup 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
Receives: Biological: Fludarabine plus Darbopoetin
fludarabine monoActive 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.
Receives: Drug: Fludarabine mono

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival

    defined as the time from initial randomization/stratification to the time-point of progressive disease, new therapy, or death)

    Measured: up to 24 months after the last dose of study medication

Secondary outcomes (2)

  1. Response Rate

    Restaging after the end of treatment included evaluation of the peripheral blood and physical examination; use of imaging techniques (ultrasound and conventional radiography or computertomography) and evaluation of the bone marrow were mandatory to assign a complete remission

    Measured: 2 months after the end of the last cycle

  2. toxicity

    adverse events were reported according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC version 2.0).

    Measured: 28 days after the end of the last cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2006 (estimated)
  2. Study startSep 2004
  3. Primary completionMay 2008
  4. Study completionOct 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00281892
Sponsor's protocol ID
CLL9
Other IDs
GCLLSG-CLL9, EU-20561, AMGEN-GCLLSG-CLL9, 2005-003014-15, 2005
Status last verified
May 2018
First submitted
24 Jan 2006
Last updated
11 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26293380

  • Goede 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.

    PubMed 26377031

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fludarabine plus Darbopoetin and Fludarabine mono in people with Chronic Lymphocytic Leukemia and Anemia, run by German CLL Study Group at 46 sites in Germany.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival (time frame: up to 24 months after the last dose of study medication). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00281892, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.

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