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A Study to Assess the Efficacy of Rituximab (MabThera) in First Line Treatment of Chronic Lymphocytic Leukemia (CLL) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Assess the Efficacy of Rituximab (MabThera) in First Line Treatment of Chronic Lymphocytic Leukemia (CLL)

Multicentre, Non-Randomised, Open-Label Phase II Study to Evaluate the Efficacy and Safety of Induction Treatment With Rituximab, Fludarabine, Cyclophosphamide, Followed by Rituximab Maintenance Therapy (R-Fc-Rm) in the First Line Treatment of Chronic Lymphocytic Leukaemia

NCT00545714•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This single arm study will assess the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide, followed by rituximab maintenance therapy, as first line treatment of participants with CLL.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•CLL according to World Health Organization diagnostic criteria
•Active disease
•No previous treatment
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion Criteria

•Transformation to aggressive B-cell malignancy (prolymphocytic leukemia, large-cell lymphoma, Hodgkin's lymphoma)
•Other malignancies except for localized skin cancer
•Continuous systemic corticosteroid treatment
•Known infection with hepatitis B or C

Locations (33)

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

Key Dates

Start Date

November 21, 2007

Primary Completion Date

May 20, 2016

Completion Date

May 20, 2016

Last Updated

January 16, 2019

Enrollment

ACTUAL participants

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Cyclophosphamide

DRUG

Fludarabine

DRUG

Rituximab

DRUG

Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers

NCT07162181

Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell+1 more

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COMPLETEDPHASE1

A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

NCT04210219

Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the Efficacy of Rituximab (MabThera) in First Line Treatment of Chronic Lymphocytic Leukemia (CLL)

Inclusion Criteria

Exclusion Criteria

Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers

A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

A Study to Assess Safety of ImbruvicaTM in Indian Participants With Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy or Chronic Lymphocytic Leukemia With 17p Deletion

A Study to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, Whose Disease Has Failed Treatment With Both BTKi and BCL2i Therapies

A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice

A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma