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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 is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01271010
First received: January 4, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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: rituximab [MabThera]
Drug: fludarabine
Drug: cyclophosphamide
 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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
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: cyclophosphamide
250 mg/m2 intravenously or orally on Days 1-3 of cycles 1-6 of 28 days length each

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271010

Contacts
Contact: Please reference Study ID Number: ML25136 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Russian Federation
Recruiting
Irkutsk, Russian Federation, 664079
Recruiting
Kemerovo, Russian Federation, 650066
Not yet recruiting
Khabarovsk, Russian Federation, 680009
Recruiting
Krasnodar, Russian Federation, 350040
Recruiting
Moscow, Russian Federation, 125101
Not yet recruiting
Moscow, Russian Federation, 115478
Recruiting
Saint-petersburg, Russian Federation, 198205
Recruiting
St Petersburg, Russian Federation
Recruiting
St. Petersburg, Russian Federation, 197110
Completed
Tula, Russian Federation, 300053
Completed
UFA, Russian Federation, 450005
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01271010     History of Changes
Other Study ID Numbers: ML25136
Study First Received: January 4, 2011
Last Updated: May 7, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation

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

ClinicalTrials.gov processed this record on May 21, 2013