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A Study of MabThera (Rituximab) in First Line Treatment of Chronic Lymphocytic Leukemia.

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: October 16, 2007
Last updated: August 1, 2016
Last verified: August 2016
This single arm study will assess the efficacy and safety of MabThera in combination with fludarabine and cyclophosphamide, followed by MabThera maintenance therapy, as first line treatment of patients with chronic lymphocytic leukemia. Patients will receive 6 cycles of treatment with MabThera (375mg/m2 i.v. on day 1 of cycle 1, and 500mg/m2 i.v. on day 1 of cycles 2-6), fludarabine (25mg/m2 on days 1-3) and cyclophosphamide (250mg/m2 on days 1-3). Patients with a partial or complete response will receive maintenance treatment with MabThera (375mg/m2 i.v. every 2 months). The anticipated time on study treatment is 2+ years, and the target sample size is <100 individuals.

Condition Intervention Phase
Lymphocytic Leukemia, Chronic
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: rituximab [MabThera/Rituxan]
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Assess the Effect of First Line Treatment With MabThera in Combination With Fludarabine and Cyclophosphamide, Followed by MabThera Monotherapy, on Response Rate in Patients With Chronic Lymphocytic Leukemia.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Response rate, and percentage of patients with molecular remission [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PFS, overall survival, treatment-free survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: November 2007
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Cyclophosphamide
250mg/m2 iv on days 1-3
Drug: Fludarabine
25mg/m2 on days 1-3
Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv on day 1 of cycle 1; 500mg/m2 iv on day 1 of cycles 2-6


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, 18-70 years of age;
  • CD20-positive B-cell chronic lymphocytic leukemia;
  • active disease;
  • no previous treatment.

Exclusion Criteria:

  • transformation to aggressive B-cell malignancy;
  • history of other malignancies except for localised skin cancer;
  • continuous systemic corticosteroid treatment;
  • known infection with hepatitis B or C.
  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 identifier: NCT00545714

Vitoria, Alava, Spain, 01009
Cádiz, Cadiz, Spain, 11009
Jerez de La Frontera, Cadiz, Spain, 11407
Santander, Cantabria, Spain, 39008
La Coruna, La Coruña, Spain, 15006
Alcorcon, Madrid, Spain, 28922
Mostoles, Madrid, Spain, 28935
Gandia, Valencia, Spain, 46702
Sagunto, Valencia, Spain, 46520
Bilbao, Vizcaya, Spain, 48013
Badajoz, Spain, 06080
Barcelona, Spain, 08907
Caceres, Spain, 10003
Castellon, Spain, 12004
Granada, Spain, 18014
Madrid, Spain, 28007
Madrid, Spain, 28034
Madrid, Spain, 28040
Madrid, Spain, 28041
Madrid, Spain, 28046
Madrid, Spain, 28050
Madrid, Spain, 28222
Madrid, Spain, 28805
Madrid, Spain, 28905
Malaga, Spain, 29010
Murcia, Spain, 30008
Salamanca, Spain, 37007
Valencia, Spain, 46014
Valencia, Spain, 46015
Valencia, Spain, 46017
Valencia, Spain, 46026
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT00545714     History of Changes
Other Study ID Numbers: ML21135 
Study First Received: October 16, 2007
Last Updated: August 1, 2016
Health Authority: Spain: Agencia Espanola del Medicamento y Productos Sanitarios

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites processed this record on September 23, 2016