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

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ClinicalTrials.gov Identifier: NCT01271010
Recruitment Status : Terminated
First Posted : January 6, 2011
Results First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This multi-center, single-arm study evaluated 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 or disease Intervention/treatment Phase
Lymphocytic Leukemia, Chronic Drug: Cyclophosphamide Drug: Fludarabine Drug: Rituximab Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
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
Actual Study Start Date : June 17, 2011
Actual Primary Completion Date : May 4, 2016
Actual Study Completion Date : May 4, 2016


Arm Intervention/treatment
Experimental: Rituximab + Fludarabine + Cyclophosphamide
Participants received 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 was 6 cycles, 28 days each.
Drug: Cyclophosphamide
Participants received cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle.
Drug: Fludarabine
Participants received fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle.
Drug: Rituximab
Participants received 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



Primary Outcome Measures :
  1. Percentage of Participants With Complete Remission [ Time Frame: Up to approximately 5 years ]
    Complete remission was defined as the disappearance of all signs of disease.

  2. Percentage of Participants With Disease Progression [ Time Frame: Up to approximately 5 years ]
    Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.

  3. Percentage of Participants With Stable Disease [ Time Frame: Up to approximately 5 years ]
    Stable disease was defined as not meeting the criteria for partial remission or disease progression

  4. Percentage of Participants With Partial Remission [ Time Frame: Up to approximately 5 years ]
    Partial remission was defined as a reduction in tumor size by >50%.

  5. Duration of Response [ Time Frame: Up to approximately 5 years ]
    Duration of Response was defined as the time period from the last day of study treatment to the day when disease progression occurred in participants who previously had complete or partial remission. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%.

  6. Progression-free Survival [ Time Frame: Up to approximately 5 years ]
    Progression-free survival was defined as the time period from the first day of study treatment to the day when disease progression occurred. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.

  7. Event-free Survival [ Time Frame: Up to approximately 5 years ]
    Event-free survival was defined as the time period from the first day of study treatment to occurrence of any of the following events: appearance of disease progression or relapse; prescription of a new treatment for disease relapse; death caused by B-cell chronic lymphocytic leukemia (B-CLL); or complications from B-CLL or therapy. Relapse was defined as disease progression in participants with complete or partial remission lasting at least 6 months after treatment completion. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%.

  8. Overall Survival [ Time Frame: Up to approximately 5 years ]
    Overall survival was defined as the time period from the first day of study treatment to participant death.

  9. Percentage of Participants With Phenotypic Remission [ Time Frame: Up to approximately 5 years ]
    Phenotypic remission was considered achieved if a participant had a negative test for minimal residual disease. A negative test for minimal residual disease was defined as tumor cells ≤0.01% of the total number of peripheral leukocytes.

  10. Percentage of Participants With Adverse Events (AEs) and Serious AEs [ Time Frame: Up to approximately 5 years ]
    An AE was defined as any unfavorable medical occurrence in a participant receiving a study drug, regardless of relationship the study drug. An AE was considered serious if it met any of the following criteria: was fatal or life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was clinically significant and/or required an intervention to prevent any of the listed criteria.



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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

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
The order of Honour pin Irkutsk regional clinical hospital; Hematology Department
Irkutsk, Russian Federation, 664079
Kemerovo Regional Clinical Hospital
Kemerovo, Russian Federation, 650066
Regional Clinical Oncology Despensary #1; Hematology Department
Krasnodar, Russian Federation, 350040
N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
Moscow, Russian Federation, 115478
City Clinical Hospital After Botkin; Hematology
Moscow, Russian Federation, 125101
City Clinical Hospital #15; Hematology department
Saint-Petersburg, Russian Federation, 198205
Leningrad Regional Clinical Hospital; Hematology #1
St Petersburg, Russian Federation
Saint-Petersburg SHI City Clinical Hospital #31
St. Petersburg, Russian Federation, 197110
GUZ Tula Regioanal Clinical Hospital; Hematology
Tula, Russian Federation, 300053
Republican clinical hospital named after G.G. Kuvatov
UFA, Russian Federation, 450005
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01271010     History of Changes
Other Study ID Numbers: ML25136
First Posted: January 6, 2011    Key Record Dates
Results First Posted: March 20, 2018
Last Update Posted: March 20, 2018
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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