A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.
A Phase II Multicenter Open-label Study of MabThera(Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma
2 other identifiers
interventional
8
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2010
Typical duration for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 14, 2010
CompletedFirst Posted
Study publicly available on registry
June 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
August 29, 2016
CompletedOctober 18, 2016
July 1, 2016
4.2 years
June 14, 2010
June 20, 2016
August 31, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 50 months (approximately)
Secondary Outcomes (3)
Overall Survival (OS)
From the time of enrollment until death due to any cause (up to 50 months [approximately])
Progression-free Survival (PFS)
From the time of enrollment until death due to any cause (up to 50 months [approximately])
Number of Participant With Adverse Event (AE)
Up to 50 months (approximately)
Study Arms (1)
Rituximab
EXPERIMENTALRituximab, 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).
Interventions
375 mg/m\^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Brasov, 500326, Romania
Unknown Facility
Bucharest, 005098, Romania
Unknown Facility
Bucharest, 022328, Romania
Unknown Facility
Bucharest, 030171, Romania
Unknown Facility
Cluj-Napoca, 400015, Romania
Unknown Facility
Iași, 700111, Romania
Unknown Facility
Târgu Mureş, 540136, Romania
Unknown Facility
Timișoara, 300079, Romania
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was prematurely terminated with 8 participants enrolled, all of them are included into the statistical analyses.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2010
First Posted
June 15, 2010
Study Start
June 1, 2010
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
October 18, 2016
Results First Posted
August 29, 2016
Record last verified: 2016-07