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A Study of MabThera (Rituximab) in Combination With Fludarabine and Cyclophosphamide in Patients With Chronic Lymphocytic Leukemia And Favorable Somatic Status

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: January 4, 2011
Last updated: August 1, 2016
Last verified: August 2016
This multi-center, single-arm study will evaluate the efficacy and safety of MabThera (rituximab) in combination with fludarabine and cyclophosphamide in patients with B-cell chronic lymphocytic leukemia and favorable somatic status. Patients will receive MabThera 375 mg/m2 intravenously on Day 1 of Cycle 1, and then 500 mg/m2 on Day 1 of the following 5 cycles, fludarabine 25 mg/m2 intravenously or 40 mg/m2 orally on Days 1-3 of every cycle and cyclophosphamide 250 mg/m2 intravenously or orally on Days 1-3 of every cycle. The anticipated time on study drug is 6 months.

Condition Intervention Phase
Lymphocytic Leukemia, Chronic
Drug: cyclophosphamide
Drug: fludarabine
Drug: rituximab [MabThera]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Study of Efficacy and Safety of RFC (Rituximab, Fludarabine, Cyclophosphamide) Regimen as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Favorable Somatic Status

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Therapy response rate of MabThera in combination with fludarabine and cyclophosphamide [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Event-free survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Reasons for different efficacy and safety of MabThera in patients [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: June 2011
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: cyclophosphamide
250 mg/m2 intravenously or orally on Days 1-3 of cycles 1-6 of 28 days length each
Drug: fludarabine
25 mg/m2 intravenously or 40 mg/m2 orally on Days 1-3 of cycles 1-6 of 28 days lengths each
Drug: rituximab [MabThera]
375 mg/m2 intravenously on Day 1 of Cycle 1, then 500 mg/m2 intravenously on Day 1 of 5 cycles of 28 days lengths


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

Inclusion Criteria:

  • Adult patients, age 18-70 years
  • Diagnosis of previously untreated B-cell chronic lymphocytic leukemia
  • For patients, age 60-70 years: Cumulative Illness Rating Scale (CIRS) comorbidity score </=6
  • Binet stage B, C or A with progression
  • Life expectancy >/=12 months
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

  • Patients with small-cell lymphoma
  • Patients with auto-immune hemolytic anemia
  • Concomitant malignant disease during enrollment, except basal cell carcinoma of the skin
  • Chemotherapy for concomitant disease give within 12 months prior to study enrollment
  • Patients with Richter's Syndrome
  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: NCT01271010

Russian Federation
Irkutsk, Russian Federation, 664079
Kemerovo, Russian Federation, 650066
Krasnodar, Russian Federation, 350040
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 125101
Saint-Petersburg, Russian Federation, 198205
St Petersburg, Russian Federation
St. Petersburg, Russian Federation, 197110
Tula, Russian Federation, 300053
UFA, Russian Federation, 450005
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01271010     History of Changes
Other Study ID Numbers: ML25136 
Study First Received: January 4, 2011
Last Updated: August 1, 2016
Health Authority: Russia: Ministry of Health of the Russian Federation

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
Antiviral Agents
Anti-Infective Agents processed this record on October 27, 2016