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A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01271010
First Posted: January 6, 2011
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This multi-center, single-arm study will evaluate the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide in participants with B-cell chronic lymphocytic leukemia (CLL) and favorable somatic status.

Condition Intervention Phase
Lymphocytic Leukemia, Chronic Drug: Cyclophosphamide Drug: Fludarabine Drug: Rituximab Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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:
  • Percentage of Participants With Therapy Response (Complete Remission, Partial Remission, Stable Disease, and Disease Progression) as Assessed by the Investigator Based on Physical Examination, Hematology, ECOG PS, and Radiology [ Time Frame: Baseline until disease progression or death due to any cause (up to approximately 60 months) ]
  • Duration of Response as Assessed by the Investigator Based on Physical Examination, Hematology, ECOG PS, and Radiology [ Time Frame: Baseline until disease progression or death due to any cause (up to approximately 60 months) ]
  • Overall Survival [ Time Frame: Baseline until death due to any cause (up to approximately 60 months) ]
  • Progression-Free Survival as Assessed by the Investigator Based on Physical Examination, Hematology, ECOG PS, and Radiology [ Time Frame: Baseline until disease progression or death due to any cause (up to approximately 60 months) ]
  • Event-Free Survival as Assessed by the Investigator Based on Physical Examination, Hematology, ECOG PS, and Radiology [ Time Frame: Baseline until disease progression or death due to any cause (up to approximately 60 months) ]
  • Percentage of Participants with Primary Resistance to Therapy [ Time Frame: Baseline until disease progression or death due to any cause (up to approximately 60 months) ]
  • Percentage of Participants Who Achieved Minimal Residual Disease (MRD) Negativity [ Time Frame: Baseline until disease progression or death due to any cause (up to approximately 60 months) ]
  • Percentage of Participants with Adverse Events [ Time Frame: Baseline up to approximately 60 months ]

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: Rituximab + Fludarabine + Cyclophosphamide
Participants will receive, rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle; fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle and cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle. Treatment duration is 6 cycles, 28 days each.
Drug: Cyclophosphamide
Participants will receive cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle.
Drug: Fludarabine
Participants will receive fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle.
Drug: Rituximab
Participants will receive, 375 mg/m^2 IV on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle.
Other Name: MabThera

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosis of previously untreated B-cell CLL confirmed immunophenotypically
  • For participants, age 60-70 years: Cumulative Illness Rating Scale (CIRS) comorbidity score less than or equal to (</=) 6
  • Binet stage B, C or A with progression
  • Life expectancy greater than or equal to (>/=) 12 months
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
  • Women of child bearing potential and men should agree to use highly reliable contraceptive method throughout the treatment period and within 12 months after treatment completion

Exclusion Criteria:

  • Participants with small-cell lymphoma
  • Participants with auto-immune hemolytic anemia
  • Concomitant malignant disease during enrollment, except basal cell carcinoma of the skin
  • Chemotherapy for concomitant malignant disease given within 12 months prior to study enrollment
  • Participants with Richter's Syndrome
  • Participants with symptomatic Hepatitis B infection
  • Any clinically significant infection that could not be cured prior to enrollment, including Human Immunodeficiency Virus (HIV) infection
  • Creatinine clearance less than (<) 30 milliliters per minute (mL/min)
  • Participants with congestive heart failure (CHF) New York Heart Association (NYHA) III-IV
  • Participants with liver failure and acute hepatitis of any etiology
  • Any other medical or mental condition which may preclude from receiving the entire course of protocol specified treatment or signing the informed consent
  • History of an anaphylactic reaction to murine antibodies, proteins, or any other ingredient of rituximab
  • Pregnancy and breast-feeding women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271010


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01271010     History of Changes
Other Study ID Numbers: ML25136
First Submitted: January 4, 2011
First Posted: January 6, 2011
Last Update Posted: November 2, 2016
Last Verified: November 2016

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