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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

Primary Purpose

Lymphocytic Leukemia, Chronic

Status
Terminated
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Chlorambucil
Cyclophosphamide
Fludarabine
Rituximab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphocytic Leukemia, Chronic

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The order of Honour pin Irkutsk regional clinical hospital; Hematology Department
  • Kemerovo Regional Clinical Hospital
  • N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
  • City Clinical Botkin's Hospital; City Hematological Center
  • City Clinical Hospital #15; Hematology department
  • Saint-Petersburg SHI City Clinical Hospital #31
  • GUZ Tula Regioanal Clinical Hospital; Hematology
  • Republican clinical hospital named after G.G. Kuvatov

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FCR-lite

LR Therapy

Arm Description

Rituximab, fludarabine, and cyclophosphamide

Rituximab and chlorambucile

Outcomes

Primary Outcome Measures

Percentage of Participants With Complete Remission
Complete remission was defined as the disappearance of all signs of disease.
Percentage of Participants With Disease Progression
Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.
Percentage of Participants With Stable Disease
Stable disease was defined as not meeting the criteria for partial remission or disease progression
Percentage of Participants With Partial Remission
Partial remission was defined as a reduction in tumor size by >50%.
Duration of Response
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%.
Progression-free Survival
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.
Event-free Survival
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%.
Overall Survival
Overall survival was defined as the time period from the first day of study treatment to participant death.
Percentage of Participants With Phenotypic Remission
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.
Percentage of Participants With Adverse Events (AEs) and Serious AEs
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.

Secondary Outcome Measures

Full Information

First Posted
January 18, 2011
Last Updated
November 23, 2018
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01283386
Brief Title
A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Study Start Date
April 27, 2011 (Actual)
Primary Completion Date
March 16, 2016 (Actual)
Study Completion Date
March 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphocytic Leukemia, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FCR-lite
Arm Type
Experimental
Arm Description
Rituximab, fludarabine, and cyclophosphamide
Arm Title
LR Therapy
Arm Type
Active Comparator
Arm Description
Rituximab and chlorambucile
Intervention Type
Drug
Intervention Name(s)
Chlorambucil
Intervention Description
10 mg/m^2 orally on Days 1-7 of each 28-day cycle for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
150 mg/m^2 IV or orally on Days 1-3 of each 28-day cycle for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
20 mg/m^2 IV or 32 mg/m2 orally Days 1-3 of each 28-day cycle for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
MabThera
Intervention Description
375 mg/m2 IV on Day 1 of Cycle 1; 500 mg/m2 IV on Day 1 of Cycles 2-6 (28-day cycles)
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Remission
Description
Complete remission was defined as the disappearance of all signs of disease.
Time Frame
Up to approximately 5 years
Title
Percentage of Participants With Disease Progression
Description
Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.
Time Frame
Up to approximately 5 years
Title
Percentage of Participants With Stable Disease
Description
Stable disease was defined as not meeting the criteria for partial remission or disease progression
Time Frame
Up to approximately 5 years
Title
Percentage of Participants With Partial Remission
Description
Partial remission was defined as a reduction in tumor size by >50%.
Time Frame
Up to approximately 5 years
Title
Duration of Response
Description
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%.
Time Frame
Up to approximately 5 years
Title
Progression-free Survival
Description
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.
Time Frame
Up to approximately 5 years
Title
Event-free Survival
Description
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%.
Time Frame
Up to approximately 5 years
Title
Overall Survival
Description
Overall survival was defined as the time period from the first day of study treatment to participant death.
Time Frame
Up to approximately 5 years
Title
Percentage of Participants With Phenotypic Remission
Description
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.
Time Frame
Up to approximately 5 years
Title
Percentage of Participants With Adverse Events (AEs) and Serious AEs
Description
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.
Time Frame
Up to approximately 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
The order of Honour pin Irkutsk regional clinical hospital; Hematology Department
City
Irkutsk
ZIP/Postal Code
664079
Country
Russian Federation
Facility Name
Kemerovo Regional Clinical Hospital
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
City Clinical Botkin's Hospital; City Hematological Center
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
City Clinical Hospital #15; Hematology department
City
Saint-Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Saint-Petersburg SHI City Clinical Hospital #31
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
GUZ Tula Regioanal Clinical Hospital; Hematology
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Republican clinical hospital named after G.G. Kuvatov
City
UFA
ZIP/Postal Code
450005
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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