Back to resultsA Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.
Primary Purpose
Diffuse Large B-Cell Lymphoma
Status
Terminated
Phase
Phase 2
Locations
Romania
Study Type
Interventional
Intervention
Cyclophosphamide
Fludarabine
Mitoxantrone
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- adult participants, >/=18 years of age
- untreated Mantle Cell Lymphoma, not eligible for Autologous Stem Cell Transplantation
- known mantle cell lymphoma international prognostic index (MIPI) at diagnosis
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- adequate hematological, renal and hepatic function
Exclusion Criteria:
- known hypersensitivity to murine proteins or chemotherapy regimen
- previous first-line therapy
- history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma
- active infection
- clinically significant cardiac disease
- regular corticosteroid treatment in the 4 weeks prior to first dose of study drug
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rituximab
Arm Description
Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR)
Overall Response Rate (ORR) was determined by tumor response according to International Workshop Group to Standardize Response Criteria for mantle cell lymphoma (MCL) criteria from confirmed evaluations of both target, radiographically evaluated, and non-target lesions. A responder is defined as a subject experiencing either a complete (CR)/ unconfirmed complete (Cru), or partial response (PR) by these criteria. As per criteria; CR = disappearance of all evidence of disease; CRu = the sum of the product of the diameters (SPD) of multiple nodes decreased by at least 75%; PR = regression of measurable disease and no new sites.
Secondary Outcome Measures
Overall Survival (OS)
Overall survival is defined as time from date of enrollment to the date of death, regardless of the cause of death.
Progression-free Survival (PFS)
PFS is defined as the interval between the day of enrollment and the first documentation of progressive disease or death. Progression of disease is defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
Number of Participant With Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01144403
Brief Title
A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.
Official Title
A Phase II Multicenter Open-label Study of MabThera(Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Study Start Date
June 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Participants will receive MabThera (372 mg/m^2 intravenously) on Day 1 of each 28-day treatment cycle in addition to standard chemotherapy for 6 cycles. In participants experiencing complete or partial response, MabThera will be continued as consolidation therapy for 2 more cycles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rituximab
Arm Type
Experimental
Arm Description
Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
as prescribed, 6 cycles
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
as prescribed, 6 cycles
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone
Intervention Description
as prescribed, 6 cycles
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Mabthera/Rituxan
Intervention Description
375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
Overall Response Rate (ORR) was determined by tumor response according to International Workshop Group to Standardize Response Criteria for mantle cell lymphoma (MCL) criteria from confirmed evaluations of both target, radiographically evaluated, and non-target lesions. A responder is defined as a subject experiencing either a complete (CR)/ unconfirmed complete (Cru), or partial response (PR) by these criteria. As per criteria; CR = disappearance of all evidence of disease; CRu = the sum of the product of the diameters (SPD) of multiple nodes decreased by at least 75%; PR = regression of measurable disease and no new sites.
Time Frame
Up to 50 months (approximately)
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival is defined as time from date of enrollment to the date of death, regardless of the cause of death.
Time Frame
From the time of enrollment until death due to any cause (up to 50 months [approximately])
Title
Progression-free Survival (PFS)
Description
PFS is defined as the interval between the day of enrollment and the first documentation of progressive disease or death. Progression of disease is defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.
Time Frame
From the time of enrollment until death due to any cause (up to 50 months [approximately])
Title
Number of Participant With Adverse Event (AE)
Description
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment.
Time Frame
Up to 50 months (approximately)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult participants, >/=18 years of age
untreated Mantle Cell Lymphoma, not eligible for Autologous Stem Cell Transplantation
known mantle cell lymphoma international prognostic index (MIPI) at diagnosis
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
adequate hematological, renal and hepatic function
Exclusion Criteria:
known hypersensitivity to murine proteins or chemotherapy regimen
previous first-line therapy
history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma
active infection
clinically significant cardiac disease
regular corticosteroid treatment in the 4 weeks prior to first dose of study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Brasov
ZIP/Postal Code
500326
Country
Romania
City
Bucharest
ZIP/Postal Code
005098
Country
Romania
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
City
Bucuresti
ZIP/Postal Code
030171
Country
Romania
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
City
Iasi
ZIP/Postal Code
700111
Country
Romania
City
Targu-mures
ZIP/Postal Code
540136
Country
Romania
City
Timisoara
ZIP/Postal Code
300079
Country
Romania
12. IPD Sharing Statement
Learn more about this trial
A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.
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