A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.
|ClinicalTrials.gov Identifier: NCT01144403|
Recruitment Status : Terminated
First Posted : June 15, 2010
Results First Posted : August 29, 2016
Last Update Posted : October 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-Cell Lymphoma||Drug: Cyclophosphamide Drug: Fludarabine Drug: Mitoxantrone Drug: Rituximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2010|
|Primary Completion Date :||August 2014|
|Study Completion Date :||August 2014|
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).
as prescribed, 6 cyclesDrug: Fludarabine
as prescribed, 6 cyclesDrug: Mitoxantrone
as prescribed, 6 cyclesDrug: Rituximab
375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles
Other Name: Mabthera/Rituxan
- Overall Response Rate (ORR) [ Time Frame: Up to 50 months (approximately) ]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.
- Overall Survival (OS) [ Time Frame: From the time of enrollment until death due to any cause (up to 50 months [approximately]) ]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) [ Time Frame: From the time of enrollment until death due to any cause (up to 50 months [approximately]) ]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) [ Time Frame: Up to 50 months (approximately) ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144403
|Brasov, Romania, 500326|
|Bucharest, Romania, 005098|
|Bucharest, Romania, 022328|
|Bucuresti, Romania, 030171|
|Cluj-Napoca, Romania, 400015|
|Iasi, Romania, 700111|
|Targu-mures, Romania, 540136|
|Timisoara, Romania, 300079|
|Study Director:||Clinical Trials||Hoffmann-La Roche|