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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545714
First received: October 16, 2007
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Lymphocytic Leukemia, Chronic
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Rituximab
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: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Complete Response (CR) Based on Protocol Specified Criteria [ Time Frame: Up to approximately 95 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants With CR or PR With Negative Minimal Residual Disease (MRD) as Assessed by Multiparameter Flow Cytometry [ Time Frame: After Cycle 6, every 3 cycles thereafter, at early study discontinuation or disease progression (maximum up to approximately 95 months) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Genetic Abnormality by Abnormality [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 95 months ] [ Designated as safety issue: No ]
  • Percentage of Participants With CR and Incomplete Bone Marrow Recovery (CRi) as Assessed Based on Protocol Specified Criteria [ Time Frame: After Cycle 6, every 3 cycles thereafter, at early study discontinuation or disease progression (maximum up to approximately 95 months) ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Up to approximately 95 months ] [ Designated as safety issue: No ]
  • Progression-free Survival (PFS) as Assessed Based on Protocol Specified Criteria [ Time Frame: Up to approximately 95 months ] [ Designated as safety issue: No ]
  • Treatment-free Survival [ Time Frame: Up to approximately 95 months ] [ Designated as safety issue: No ]
  • Duration of Response as Assessed Based on Protocol Specified Criteria [ Time Frame: Up to approximately 95 months ] [ Designated as safety issue: No ]
  • Percentage of Participants With Cluster of Differentiation (CD)-38 Cells Greater Than [>] or Less Than [<] 30 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Percentage of Participants With Positive or Negative ZAP-70 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Percentage of Participants With IgH Rearrangement [ Time Frame: Baseline ] [ 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: Rituximab + Fludarabine + Cyclophosphamide
Participants will receive 6 cycles (1 cycle = 28 days) of treatment with rituximab (375 milligrams per meter-squared [mg/m^2] as intravenous [IV] infusion on Day 1 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 to 3) and cyclophosphamide (250 mg/m^2 on Days 1 to 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.
Drug: Cyclophosphamide
Cyclophosphamide 250 mg/m^2 as IV infusion will be administered on Days 1 to 3 of first six 28-day cycles.
Drug: Fludarabine
Fludarabine 25 mg/m^2 as IV infusion will be administered on Days 1 to 3 of first six 28-day cycles.
Drug: Rituximab
Rituximab 375 mg/m^2 as IV infusion will be administered on Day 1 of Cycle 1; 500 mg/m^2 as IV infusion will be administered on Day 1 of Cycle 2 to 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 Name: MabThera, Rituxan

  Eligibility

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

Inclusion Criteria:

  • Cluster of Differentiation (CD) 20-positive B-cell CLL
  • 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
  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 ClinicalTrials.gov identifier: NCT00545714

Locations
Spain
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Cyclophosphamide
Fludarabine phosphate
Rituximab
Fludarabine
Vidarabine
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
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on December 09, 2016