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 is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: January 18, 2011
Last updated: April 2, 2016
Last verified: April 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
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
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 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
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
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Please refer to this study by its ClinicalTrials.gov 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
ClinicalTrials.gov Identifier: NCT01283386     History of Changes
Other Study ID Numbers: ML25137 
Study First Received: January 18, 2011
Last Updated: April 2, 2016
Health Authority: Russia: Ministry of Health of the Russian Federation

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

ClinicalTrials.gov processed this record on April 27, 2016