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

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.
 
ClinicalTrials.gov Identifier: NCT01283386
Recruitment Status : Terminated
First Posted : January 26, 2011
Results First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This multi-center, randomized study compared the efficacy and safety of MabThera (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil in participants with previously untreated B-cell chronic lymphocytic leukemia and unfavorable somatic status. Participants were 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 was 24 weeks.

Condition or disease Intervention/treatment Phase
Lymphocytic Leukemia, Chronic Drug: Chlorambucil Drug: Cyclophosphamide Drug: Fludarabine Drug: Rituximab Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : April 27, 2011
Actual Primary Completion Date : March 16, 2016
Actual Study Completion Date : March 16, 2016


Arm Intervention/treatment
Experimental: FCR-lite
Rituximab, fludarabine, and cyclophosphamide
Drug: Cyclophosphamide
150 mg/m^2 IV or orally on Days 1-3 of each 28-day cycle for 6 cycles

Drug: Fludarabine
20 mg/m^2 IV or 32 mg/m2 orally Days 1-3 of each 28-day cycle for 6 cycles

Drug: Rituximab
375 mg/m2 IV on Day 1 of Cycle 1; 500 mg/m2 IV on Day 1 of Cycles 2-6 (28-day cycles)
Other Name: MabThera

Active Comparator: LR Therapy
Rituximab and chlorambucile
Drug: Chlorambucil
10 mg/m^2 orally on Days 1-7 of each 28-day cycle for 6 cycles

Drug: Rituximab
375 mg/m2 IV on Day 1 of Cycle 1; 500 mg/m2 IV on Day 1 of Cycles 2-6 (28-day cycles)
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:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01283386


Locations
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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
N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
Moscow, Russian Federation, 115478
City Clinical Botkin's Hospital; City Hematological Center
Moscow, Russian Federation, 125284
City Clinical Hospital #15; Hematology department
Saint-Petersburg, Russian Federation, 198205
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
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01283386    
Other Study ID Numbers: ML25137
First Posted: January 26, 2011    Key Record Dates
Results First Posted: March 14, 2019
Last Update Posted: March 14, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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
Chlorambucil
Rituximab
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological