Study of Bortezomib in Combination With Cyclophosphamide and Rituximab
|ClinicalTrials.gov Identifier: NCT00958256|
Recruitment Status : Completed
First Posted : August 13, 2009
Results First Posted : April 13, 2015
Last Update Posted : April 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma Lymphoma||Drug: Bortezomib Drug: Rituximab Drug: Cyclophosphamide Drug: Mesna Drug: G-CSF||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Bortezomib in Combination With Cyclophosphamide and Rituximab for Relapsed/Refractory Mantle Cell Lymphoma|
|Study Start Date :||August 2009|
|Primary Completion Date :||March 2014|
|Study Completion Date :||March 2014|
Experimental: Bortezomib with Cyclophosphamide and Rituximab
Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
Bortezomib 1.3 mg/m^2 given intravenously over 3-5 seconds at the end of infusion of Rituximab on Day 1 of every cycle, then on Days 4, 8 and 11 of every cycle.
Other Name: VelcadeDrug: Rituximab
375 mg/m^2 given intravenously over 6-8 hours on Day 1 of every 21-day study cycle.
Other Name: RituxanDrug: Cyclophosphamide
300 mg/m^2 intravenously over 3 hours 2 times each day (6 hours total each day) on Days 2, 3, and 4 of every cycle
Other Names:Drug: Mesna
600 mg/m^2 intravenous continuous infusion (IVCI) over 24 hours daily for 3 days, 1 hour prior to Cyclophosphamide and complete by 12 hours after last dose of Cyclophosphamide.
Other Name: MesnexDrug: G-CSF
5 micrograms/kg subcutaneously daily starting 24-36 hours for 7 days after last dose of Bortezomib until granulocytes are more than 4 x 103/dl.
- Response Rate [ Time Frame: Evaluation of disease after 2 cycles (approximately 6 weeks). ]Response rate to regimen defined as the percentage of number of complete response or partial response in total number of participants treated. The response assessed after the first 2 cycles. Response (complete and partial remission) according to International Workshop Response Criteria for Non-Hodgkin's Lymphoma: A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease. A cycle is 21 days with 6-8 cycles administered depending on response.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958256
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jorge Romaguera, MD||M.D. Anderson Cancer Center|