Study of Bortezomib in Combination With Cyclophosphamide and Rituximab
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|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|
|Actual Primary Completion Date :||March 2014|
|Actual 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: Velcade
375 mg/m^2 given intravenously over 6-8 hours on Day 1 of every 21-day study cycle.
Other Name: Rituxan
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
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: Mesnex
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|