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A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Patients With Chronic Lymphocytic Leukemia and Unfavourable Somatic Status

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: January 18, 2011
Last updated: October 3, 2016
Last verified: October 2016
This multi-center, randomized study will compare the efficacy and safety of MabThera (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil in patients with previously untreated B-cell chronic lymphocytic leukemia and unfavourable somatic status. Patients will be randomized to receive Mabthera (375 mg/m2 intravenously [iv] Day 1 of Cycle 1, 500 mg/m2 iv Day 1 Cycles 2-6) with either fludarabine (20 mg/m2 iv or 32 mg/m2 orally Days 1-3) and cyclophosphamide (150 mg/m2 iv or orally Days 1-3) or with chlorambucil (10 mg/m2 orally Days 1-7) for 6 cycles of 28 days. Anticipated time on study treatment is 24 weeks.

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

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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Therapy response rate [ 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 ]
  • Laboratory predictors of response [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: April 2011
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: cyclophosphamide
150 mg/m2 iv or orally on Days 1-3 of each 28-day cycle, 6 cycles
Drug: fludarabine
20 mg/m2 iv or 32 mg/m2 orally Days 1-3 of each 28-day cycle, 6 cycles
Drug: rituximab [MabThera]
375 mg/m2 iv on Day 1 of cycle 1, 500 mg/m2 iv on Day 1 of cycles 2-6 (28-day cycles)
Active Comparator: B Drug: chlorambucil
10 mg/m2 orally on Days 1-7 of each 28-day cycle, 6 cycles
Drug: rituximab [MabThera]
375 mg/m2 iv on Day 1 of cycle 1, 500 mg/m2 iv on Day 1 of cycles 2-6 (28-day cycles)


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, 60-70 or >70 years of age
  • Cumulative Illness Rating Scale (CIRS) comorbidity score >/=7 if patient is 60-70 years old
  • Previously untreated B-cell chronic lymphocytic leukemia
  • Binet stage B, C or A with progression
  • ECOG performance status 0-2

Exclusion Criteria:

  • Small-cell lymphoma
  • Autoimmune hemolytic anemia
  • Concomitant malignant disease during enrollment, except for basal cell carcinoma of the skin
  • Chemotherapy for concomitant malignant disease within 12 months prior to study enrollment
  • 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: NCT01283386

Russian Federation
Irkutsk, Russian Federation, 664079
Kemerovo, Russian Federation, 650066
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 125284
Saint-Petersburg, Russian Federation, 198205
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: NCT01283386     History of Changes
Other Study ID Numbers: ML25137 
Study First Received: January 18, 2011
Last Updated: October 3, 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 21, 2016