Clinical Trial: A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL)

Brief Summary:

This study will include patients with mature T-cell lymphoma (MTCL) that has been treated with at least one type of chemotherapy, but is not responding or coming back after the previous treatment.

This clinical trial uses a drug called Brentuximab Vedotin. The Food and Drug Administration (FDA) has approved Brentuximab Vedotin for sale in the United States for certain diseases. Brentuximab is still being studied in clinical trials like this one to learn more about what its side effects are and whether or not it is effective in the disease or condition being studied.

Brentuximab Vedotin is a type of drug called an antibody drug conjugate (ADC). ADCs usually have 2 parts; a part that targets cancer cells (the antibody) and a cell killing part (the chemotherapy). Antibodies are proteins that are part of your immune system. They can stick to and attack specific targets on cells. The antibody part of Brentuximab Vedotin sticks to a target called CD30. CD30 is an important molecule on some cancer cells (including non Hodgkin lymphoma) and some normal cells of the immune system. The cell killing part of Brentuximab Vedotin is a chemotherapy called monomethyl auristatin E (MMAE). It can kill cells that the antibody part of Brentuximab Vedotin sticks to. Brentuximab Vedotin has also been shown to kill cancer cells with levels of CD30 that cannot be seen by traditional methods.

This study is being done to test if the study drug has an effect on Mature T cell Lymphoma with such low levels of a target called CD30 and how your disease respond to the study drug.


Detailed Summary:

Primary Objective

• To determine overall response rate (CR+PR) of brentuximab vedotin in CD30 low (<10%) relapsed or refractory T cell lymphoma (TCL)

Secondary Objective(s)

  • Complete remission (CR) rate
  • Duration of response (DOR)
  • Progression free survival (PFS)
  • Overall survival (OS)
  • Time to treatment failure (TTF)

Sponsor: Deepa Jagadeesh

Current Primary Outcome: Overall Response Rate [ Time Frame: Three years after end of treatment ]

The primary objective is to evaluate overall response rate (ORR). Overall response rate will be estimated by the total number of patients who achieve a CR and PR divided by the total number of evaluable patients. Response will be assessed using CT scans according to the revised Cheson criteria [1].

  • CR is defined as complete resolution of all clinically detectable disease and disease related symptoms that were present prior to therapy
  • PR is defined as at least 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses Patients should have completed at least 1 cycle of treatment to be evaluable for ORR.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Complete Response [ Time Frame: Three years after end of treatment ]
    Complete Response is defined as complete resolution of all clinically detectable disease and disease related symptoms that were present prior to therapy. A post-treatment residual mass of any size is permitted as long as it is PET negative. CR rate will be calculated by dividing the total number of patients who have achieved a complete response by the total number of evaluable patients.
  • Progression Free Survival [ Time Frame: Three years after end of treatment ]
    Progression-free survival (PFS) is defined as the time from enrollment into the study to disease progression or death due to any cause. The distribution of PFS will be estimated using the Kaplan-Meier method. Disease progression may be defined as the date of documentation of a new lesion or enlargement of a previous lesion, or the date of the scheduled clinic visit immediately after radiologic assessment has been completed. For a patient who is alive without progression at the end of study follow-up, observation of PFS is censored on the date of last contact.
  • Overall Survival [ Time Frame: Three years after end of treatment ]
    The overall survival (OS) is defined as the time from enrollment to the time of death due to any cause. For a patient who is alive at the end of study follow-up, observation of OS is censored on the date of last contact. The distribution of OS will be estimated using the Kaplan-Meier method.
  • Duration of Response [ Time Frame: Three years after end of treatment ]
    Duration of response (DOR) is defined as the time from first documentation of objective tumor response (CR or PR) to the time to tumor progression or death due to any cause.
  • Time to Treatment Failure [ Time Frame: Up to 13 months after start of treatment ]
    Time to treatment failure (TTF) is defined as the time from enrollment to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death
  • Response Review [ Time Frame: Three years after end of treatment ]
    Responses will be reviewed by the investigator (PI or co-investigator) who is treating the patient at each participating site.


Original Secondary Outcome: Same as current

Information By: Case Comprehensive Cancer Center

Dates:
Date Received: October 26, 2015
Date Started: June 2016
Date Completion: June 2020
Last Updated: January 23, 2017
Last Verified: January 2017