A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL)
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|ClinicalTrials.gov Identifier: NCT02588651|
Recruitment Status : Recruiting
First Posted : October 28, 2015
Last Update Posted : November 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|T-cell Lymphoma Angioimmunoblastic T-cell Lymphoma Hepato-splenic T-cell Lymphoma Adult T-cell Leukemia/Lymphoma Enteropathy Associated T-cell Lymphoma NK T-cell Lymphoma Transformed Mycosis Fungoides||Drug: Brentuximab vedotin||Phase 2|
• To determine overall response rate (CR+PR) of brentuximab vedotin in CD30 low (<10%) relapsed or refractory T cell lymphoma (TCL)
- Complete remission (CR) rate
- Duration of response (DOR)
- Progression free survival (PFS)
- Overall survival (OS)
- Time to treatment failure (TTF)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (<10%) Mature T Cell Lymphoma (TCL)|
|Actual Study Start Date :||June 17, 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2022|
Experimental: Brentuximab vedotin
Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks
Drug: Brentuximab vedotin
study drug given intravenously to determine efficacy in study diseases
- 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.
- 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.
- 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.
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): NCT02588651
|Contact: Deepa Jagadeesh, MD, MPHemail@example.com|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109-5413|
|Contact: Ryan Wilcox, MD firstname.lastname@example.org|
|Principal Investigator: Ryan Wilcox, MD|
|Wayne State University, Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Radhakrishnan Ramchandren, MD 313-576-8739 email@example.com|
|Principal Investigator: Radhakrishnan Ramchandren, MD|
|United States, New Jersey|
|Hackensack University Medical Center||Recruiting|
|Hackensack, New Jersey, United States, 07601|
|Contact: Tatyana Feldman, MD 551-996-5900 Tatyana.Feldman@HackensackMeridian.org|
|Principal Investigator: Tatyana Feldman, MD|
|United States, Ohio|
|University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Paolo Caimi, MD 216-844-0139 Paolo.Caimi@uhhospitals.org|
|Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Deepa Jagadeesh, MD, MPH 216-444-0857 firstname.lastname@example.org|
|Principal Investigator:||Deepa Jagadeesh, MD, MPH||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Principal Investigator:||Paolo Caimi, MD||Case Medica Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|