FCR or BR in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia
NCT ID: NCT00769522
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
564 participants
INTERVENTIONAL
2008-10-02
2018-01-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared with bendamustine and rituximab in treating patients with previously untreated B-cell chronic lymphocytic leukemia.
Detailed Description
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* To compare the therapeutic efficacy of fludarabine phosphate, cyclophosphamide, and rituximab vs bendamustine hydrochloride and rituximab in patients with previously untreated B-cell chronic lymphocytic leukemia.
* To compare the incidence of major side effects (e.g., myelosuppression) associated with these regimens in these patients.
* To compare the rate of infections and secondary neoplasias in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to country and disease stage. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive fludarabine phosphate IV and cyclophosphamide IV on days 1-3. Patients also receive rituximab IV on day 0 of course 1 and on day 1 of courses 2-6. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive bendamustine hydrochloride IV on days 1 and 2. Patients also receive rituximab as in arm I. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life questionnaires (EORTC-C30 and EURO-QOL) at baseline and then at 12, 24, 36, 48, and 60 months.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then once a year thereafter.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FCR
Rituximab
cycle 1: 375 mg/m² i.v., day 0, q28d
cycle 2-6: 500 mg/m² i.v., day 1, q28d
Cyclophosphamide
cycle 1-6: 250 mg/m² i.v., days 1-3, q28d
Fludarabine
cycle 1-6: 25 mg/m² i.v., days 1-3, q28d
BR
Rituximab
cycle 1: 375 mg/m² i.v., day 0, q28d
cycle 2-6: 500 mg/m² i.v., day 1, q28d
Bendamustine
cycle 1-6: 90mg/m² i.v., day 1-2, q28d
Interventions
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Rituximab
cycle 1: 375 mg/m² i.v., day 0, q28d
cycle 2-6: 500 mg/m² i.v., day 1, q28d
Bendamustine
cycle 1-6: 90mg/m² i.v., day 1-2, q28d
Cyclophosphamide
cycle 1-6: 250 mg/m² i.v., days 1-3, q28d
Fludarabine
cycle 1-6: 25 mg/m² i.v., days 1-3, q28d
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting 1 of the following criteria:
* Binet stage C disease or stage B or A disease requiring treatment
* Binet stage B or A disease meeting ≥ 1 of the following:
* B-symptoms (e.g., night sweats, weight loss ≥ 10% within the past 6 months, fevers \> 38°C or 100.4°F for ≥ 2 weeks without evidence of infection) or constitutional symptoms (e.g., fatigue)
* Progressive lymphocytosis, defined as peripheral lymphocyte count \> 5 x 10\^9/L (i.e., \> 50% increase over a 2-month period or doubling of peripheral blood lymphocyte count \< 6 months)
* Evidence of progressive marrow failure as manifested by the development/worsening of anemia and/or thrombocytopenia
* Massive, progressive, or painful splenomegaly or hypersplenism
* Massive lymph nodes or lymph node clusters (\> 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
* No 17p deletion by FISH
* No aggressive B-cell cancer, such as Richter syndrome
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Life expectancy ≥ 6 months
* Total bilirubin ≤ 2 times upper limit of normal (ULN) (unless directly attributable to CLL)
* AST and ALT ≤ 2 times ULN (unless directly attributable to CLL)
* Creatinine clearance ≥ 70 mL/min (creatinine clearance is to be calculated only in patients with serum creatinine ≥ 1.1 mg/dL)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
* Hepatitis B and C negative
* HIV negative
* CIRS score \> 6 or a single score of 4 for one organ category
* No active secondary malignancy requiring treatment, except basal cell carcinoma or malignant tumor curatively treated by surgery, or successfully treated secondary malignancies in complete remission \> 5 years prior to enrollment
* No history of anaphylaxis following exposure to monoclonal antibodies
* No active bacterial, viral, or fungal infection
* No medical condition requiring prolonged use of oral corticosteroids (i.e., \> 1 month)
* No cerebral dysfunction or legal incapacity
* No circumstance that would preclude completion of the study or the required follow-up
PRIOR CONCURRENT THERAPY:
* No prior CLL specific-chemotherapy, radiotherapy, and/or immunotherapy
* Prednisolone administered immediately prior to initiation of study therapy allowed for very high lymphocyte counts
* No concurrent participation in another clinical trial
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Mundipharma Pte Ltd.
INDUSTRY
German CLL Study Group
OTHER
Responsible Party
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Principal Investigators
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Barbara Eichhorst, MD
Role: PRINCIPAL_INVESTIGATOR
Medizinische Universitaetsklinik I at the University of Cologne
Locations
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Medizinische Universitaetsklinik I at the University of Cologne
Cologne, , Germany
Countries
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References
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Kurtz DM, Esfahani MS, Scherer F, Soo J, Jin MC, Liu CL, Newman AM, Duhrsen U, Huttmann A, Casasnovas O, Westin JR, Ritgen M, Bottcher S, Langerak AW, Roschewski M, Wilson WH, Gaidano G, Rossi D, Bahlo J, Hallek M, Tibshirani R, Diehn M, Alizadeh AA. Dynamic Risk Profiling Using Serial Tumor Biomarkers for Personalized Outcome Prediction. Cell. 2019 Jul 25;178(3):699-713.e19. doi: 10.1016/j.cell.2019.06.011. Epub 2019 Jul 4.
Dimier N, Delmar P, Ward C, Morariu-Zamfir R, Fingerle-Rowson G, Bahlo J, Fischer K, Eichhorst B, Goede V, van Dongen JJM, Ritgen M, Bottcher S, Langerak AW, Kneba M, Hallek M. A model for predicting effect of treatment on progression-free survival using MRD as a surrogate end point in CLL. Blood. 2018 Mar 1;131(9):955-962. doi: 10.1182/blood-2017-06-792333. Epub 2017 Dec 18.
Kutsch N, Robrecht S, Fink A, Lange E, Weide R, Kiehl MG, Sokler M, Schlag R, Vehling-Kaiser U, Kochling G, Ploger C, Gregor M, Plesner T, Clausen MR, Oschlies I, Ritgen M, Herling M, Fischer K, Dohner H, Wendtner CM, Kreuzer KA, Stilgenbauer S, Hallek M, Bottcher S, Klapper W, Eichhorst B. The role of trephine bone marrow biopsies in the era of measurable residual disease-Results from the CLL10 trial of the German CLL Study Group (GCLLSG). Hemasphere. 2024 Jul 24;8(7):e126. doi: 10.1002/hem3.126. eCollection 2024 Jul. No abstract available.
Eichhorst B, Fink AM, Bahlo J, Busch R, Kovacs G, Maurer C, Lange E, Koppler H, Kiehl M, Sokler M, Schlag R, Vehling-Kaiser U, Kochling G, Ploger C, Gregor M, Plesner T, Trneny M, Fischer K, Dohner H, Kneba M, Wendtner CM, Klapper W, Kreuzer KA, Stilgenbauer S, Bottcher S, Hallek M; international group of investigators; German CLL Study Group (GCLLSG). First-line chemoimmunotherapy with bendamustine and rituximab versus fludarabine, cyclophosphamide, and rituximab in patients with advanced chronic lymphocytic leukaemia (CLL10): an international, open-label, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2016 Jul;17(7):928-942. doi: 10.1016/S1470-2045(16)30051-1. Epub 2016 May 20.
Kovacs G, Robrecht S, Fink AM, Bahlo J, Cramer P, von Tresckow J, Maurer C, Langerbeins P, Fingerle-Rowson G, Ritgen M, Kneba M, Dohner H, Stilgenbauer S, Klapper W, Wendtner CM, Fischer K, Hallek M, Eichhorst B, Bottcher S. Minimal Residual Disease Assessment Improves Prediction of Outcome in Patients With Chronic Lymphocytic Leukemia (CLL) Who Achieve Partial Response: Comprehensive Analysis of Two Phase III Studies of the German CLL Study Group. J Clin Oncol. 2016 Nov 1;34(31):3758-3765. doi: 10.1200/JCO.2016.67.1305.
Al-Sawaf O, Robrecht S, Bahlo J, Fink AM, Cramer P, von Tresckow J, Maurer C, Bergmann M, Seiler T, Lange E, Kneba M, Stilgenbauer S, Dohner H, Kiehl MG, Jager U, Wendtner CM, Fischer K, Goede V, Hallek M, Eichhorst B, Hopfinger G. Impact of gender on outcome after chemoimmunotherapy in patients with chronic lymphocytic leukemia: a meta-analysis by the German CLL study group. Leukemia. 2017 Oct;31(10):2251-2253. doi: 10.1038/leu.2017.221. Epub 2017 Jul 12. No abstract available.
Related Links
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Click here for more information about this study: CLL10 (German CLL Study Group)
Other Identifiers
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CDR0000616169
Identifier Type: OTHER
Identifier Source: secondary_id
2007-007587-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLL10
Identifier Type: -
Identifier Source: org_study_id