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 ]

ORR: The proportion of patients with complete response (CR) and partial response (PR). Follow-up assessments after cycle 16 to be done every 12 weeks for up to 24 months. Restaging imaging computed tomography (CT) scans to be repeated 12 and 24 months from the beginning of the follow-up period. Objective disease response (CR and PR) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL). CR = Disappearance of all evidence of disease; PR = Regression of measurable disease and no new sites.


Original Primary Outcome: Overall Response Rate (ORR) [ Time Frame: 4 years ]

To evaluate the activity of Brentuximab vedotin in patients with relapsed/refractory Peripheral T cell Lymphoma (PTCL) expressing CD30 receptor. The ORR [complete response (CR)+ partial response (PR)] will be used as the primary endpoint to assess efficacy.The primary efficacy parameter is objective response rate, defined as the proportion of patients with complete response (CR) and partial response (PR). Follow-up assessments after cycle 16 will be done every 12 weeks for up to 24 months. Restaging imaging computed tomography (CT) scans will be repeated 12 and 24 months from the beginning of the follow-up period. Objective disease response (CR and PR) will be defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL). CR = Disappearance of all evidence of disease; PR = Regression of measurable disease and no new sites.


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