A Study to Assess the Efficacy of Rituximab (MabThera) in First Line Treatment of Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT00545714
Last Updated: 2019-01-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2007-11-21
2016-05-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rituximab + Fludarabine + Cyclophosphamide
Participants will receive 6 cycles (cycle length = 28 days) of treatment with rituximab (375 milligrams per square meter \[mg/m\^2\] as intravenous \[IV\] infusion on Day 0 of Cycle 1 and 500 mg/m\^2 as IV infusion on Day 1 of Cycles 2-6); fludarabine (25 mg/m\^2 on Days 1-3) and cyclophosphamide (250 mg/m\^2 on Days 1-3). Participants with a partial or complete response and appropriate neutrophil conditions will receive maintenance treatment with rituximab (375 mg/m\^2 as IV infusion every 2 months) from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6.
Cyclophosphamide
Cyclophosphamide 250 mg/m\^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles.
Fludarabine
Fludarabine 25 mg/m\^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles.
Rituximab
Rituximab 375 mg/m\^2 as IV infusion will be administered on Day 0 of Cycle 1; 500 mg/m\^2 as IV infusion will be administered on Day 1 of Cycle 2-6; and 375 mg/m\^2 as IV infusion every 2 months from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6.
Interventions
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Cyclophosphamide
Cyclophosphamide 250 mg/m\^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles.
Fludarabine
Fludarabine 25 mg/m\^2 as IV infusion will be administered on Days 1-3 of first six 28-day cycles.
Rituximab
Rituximab 375 mg/m\^2 as IV infusion will be administered on Day 0 of Cycle 1; 500 mg/m\^2 as IV infusion will be administered on Day 1 of Cycle 2-6; and 375 mg/m\^2 as IV infusion every 2 months from 3 months after Day 1 Cycle 6 up to a total of 18 doses or up to 3 years after Cycle 6.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active disease
* No previous treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Exclusion Criteria
* Other malignancies except for localized skin cancer
* Continuous systemic corticosteroid treatment
* Known infection with hepatitis B or C
18 Years
70 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Hospital De Txagorritxu; Servicio de Hematologia
Vitoria-Gasteiz, Alava, Spain
Hospital Universitario Puerta del Mar; Servicio de Hematologia
Cadiz, Cadiz, Spain
Hospital de Jerez de la Frontera; Servicio de Hematologia
Jerez de la Frontera, Cadiz, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Hematologia
Santander, Cantabria, Spain
Hospital General de Castellon; Servicio de Hematologia
Castellon, Castellon, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia
A Coruña, LA Coruña, Spain
Fundacion Hospital de Alcorcon; Servicio de Hematologia
Alcorcón, Madrid, Spain
Hosital Universitario de Mostoles;Servicio de Hematologia
Móstoles, Madrid, Spain
Hospital Francesc de Borja; Servicio de Hematologia
Gandia, Valencia, Spain
Hospital de Sagunto; Servicio de Hematologia
Sagunto, Valencia, Spain
Hospital de Basurto; Servicio de Hematologia
Bilbao, Vizcaya, Spain
Hospital Universitario Infanta Cristina; Servicio de Hematologia
Badajoz, , Spain
Hospital Duran i Reynals; Servicio de Hematologia
Barcelona, , Spain
Hospital San Pedro De Alcantara; Servicio de Hematologia
Cáceres, , Spain
Hospital Universitario Virgen de las Nieves; Servicio de Hematologia
Granada, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Hematología
Madrid, , Spain
Hospital Ramon y Cajal; Servicio de Hematologia
Madrid, , Spain
Hospital Universitario Clínico San Carlos; Servicio de Hematología
Madrid, , Spain
Hospital Univ. 12 de Octubre; Servicio de Hematologia
Madrid, , Spain
Hospital Universitario la Paz; Servicio de Hematologia
Madrid, , Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia
Madrid, , Spain
Hospital Universitario Puerta de Hierro; Servicio de Hematologia
Madrid, , Spain
Hospital Universitario Principe de Asturias; Servicio de Hematología
Madrid, , Spain
Hospital Universitario de Getafe; Servico de Hematologia
Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia
Málaga, , Spain
Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología
Murcia, , Spain
Hospital Clinico Universitario de Salamanca;Servicio de Hematologia
Salamanca, , Spain
Hospital General Universitario de Valencia; Servicio de Hematologia
Valencia, , Spain
Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia
Valencia, , Spain
Hospital Universitario Dr. Peset; Servicio de Hematologia
Valencia, , Spain
Hospital Universitario la Fe; Servicio de Hematologia
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia
Zaragoza, , Spain
Hospital Universitario Miguel Servet; Servicio Hematologia
Zaragoza, , Spain
Countries
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References
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Garcia-Marco JA, Jimenez JL, Recasens V, Zarzoso MF, Gonzalez-Barca E, De Marcos NS, Ramirez MJ, Parraga FJP, Yanez L, De La Serna Torroba J, Malo MDG, Ariznavarreta GD, Persona EP, Guinaldo MAR, De Paz Arias R, Llanos EB, Jarque I, Valle MDCF, Tatay AC, De Oteyza JP, Martin EMD, Fernandez IP, Martinez RM, Costa MAA, Champ D, Suarez JG, Diaz MG, Ferrer S, Carbonell F, Garcia-Vela JA; GELLC Study Group. High prognostic value of measurable residual disease detection by flow cytometry in chronic lymphocytic leukemia patients treated with front-line fludarabine, cyclophosphamide, and rituximab, followed by three years of rituximab maintenance. Haematologica. 2019 Nov;104(11):2249-2257. doi: 10.3324/haematol.2018.204891. Epub 2019 Mar 19.
Other Identifiers
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2007-002733-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML21135
Identifier Type: -
Identifier Source: org_study_id
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