Clinical Trial: Pilot Study of Brentuximab Vedotin in Relapsed/Refractory Peripheral T-Cell Lymphoma Expressing CD30
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Pilot Study of Brentuximab Vedotin in Relapsed/Refractory Peripheral T-Cell Lymphoma Expressing CD30 Receptor
Brief Summary: The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in patients with a certain type of large B-cell lymphoma. The side effects (unwanted effects) of SGN-35 in patients with this certain type of large B-cell lymphoma will also be studied. It is not known if brentuximab vedotin is better or worse than other treatment patients might be given.
Detailed Summary:
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Current Primary Outcome: Overall Response Rate (ORR) [ Time Frame: Up to 24 months post treatment ]
Original Primary Outcome: Overall Response Rate (ORR) [ Time Frame: 4 years ]
Current Secondary Outcome:
- Time to Response (TTR) [ Time Frame: Up to 24 months post treatment ]Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. TTR: The time from the start of treatment to the first time when the measurement criteria for CR or PR are met. Participants who did not have a confirmed response to be censored at the date of the last tumor assessment.
- Duration of Response (DOR) [ Time Frame: Up to 24 months post treatment ]DOR: The number of days between the first tumor response assessment of objective response (complete response and partial response) to the time of the first tumor response assessment of progressive disease (PD) or death if due to disease progression (date of first PD assessment or death due to disease progression-date of first objective response assessment +1).
- Time to Disease Progression (TTP) [ Time Frame: Up to 24 months post treatment ]Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Progressive disease (PD) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).
- Progression Free Survival (PFS) [ Time Frame: 24 months post treatment ]Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Stable disease (SD) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).
- Overall Survival (OS) [ Time Frame: 24 months post treatment or until study closure ]Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Radiological assessments to be discontinued at the time of tumor progression or initiation of new anticancer therapy, after which survival to be evaluated every 3 months until 2 years from the start of study treatment or until study closure.
- Number of Participants With Study Related Serious Adverse Events (SAEs) [ Time Frame: Up to 24 months post treatment ]Serious adverse events (SAEs) to be summarized by worst NCI NCI Common Terminology Criteria for Adverse Events (CTCAE) grade.
Original Secondary Outcome:
- Median Time to Response [ Time Frame: 4 years ]Objective disease response (CR and PR), stable disease (SD) and progressive disease (PD) will be defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).
- Duration of Response [ Time Frame: 4 years ]Objective disease response (CR and PR), stable disease (SD) will be defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).
- Median Time to Disease Progression [ Time Frame: 4 years ]Progressive disease (PD) will be defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).
- Number of Participants with Progression Free Survival (PFS) [ Time Frame: 4 years ]Stable disease (SD) will be defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).
- Number of Participants with Overall Survival (OS) [ Time Frame: 4 years ]Radiological assessments will be discontinued at the time of tumor progression or initiation of new anticancer therapy, after which survival will be evaluated every 3 months until 2 years from the start of study treatment or until study closure.
- Number of Participants with Study Related Serious Adverse Events (SAEs) [ Time Frame: 4 years ]Adverse events (AEs) will be summarized by worst NCI NCI Common Terminology Criteria for Adverse Events (CTCAE) grade. The patient incidence of AEs will be summarized by system organ class, preferred term, severity and relationship to study drug. Adverse events leading to death or to discontinuation from treatment, events classified as CTCAE 4.0 grade 3 or higher, study-drug-related events, and serious adverse events (SAEs) will be listed separately.
Information By: H. Lee Moffitt Cancer Center and Research Institute
Dates:
Date Received: April 24, 2013
Date Started: April 2014
Date Completion:
Last Updated: November 22, 2016
Last Verified: November 2016