A Phase II Study of Single Agent Brentuximab Vedotin in Relapsed/Refractory CD30 Low (

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Brief Title

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

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 Description

      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)
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall Response Rate

Secondary Outcome

 Complete Response

Condition

T-cell Lymphoma

Intervention

Brentuximab vedotin

Study Arms / Comparison Groups

 Brentuximab vedotin
Description:  Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

31

Start Date

June 17, 2016

Completion Date

November 2021

Primary Completion Date

November 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed relapsed/refractory CD30
             low (<10%) TCL: including peripheral TCL not otherwise specified (PTCL NOS),
             angioimmunoblastic T cell lymphoma (AITL), hepato-splenic T cell lymphoma (HTCL),
             adult T cell leukemia/lymphoma (ATLL), enteropathy associated T cell lymphoma (EATL),
             adult T cell leukemia/lymphoma (ATLL), enteropathy associated T cell lymphoma (EATL),
             NK T cell lymphoma (NK/TCL)

          -  At least 1 prior chemotherapy regimen

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. ECOG Performance
             Status (PS) 3 will be permitted if the decreased PS is attributed to the lymphoma

          -  Adequate organ function

               -  Bilirubin ≤1.5X upper limit of normal (ULN), alanine aminotransferase (ALT) and
                  aspartate aminotransferase (AST) ≤3X ULN even in patients with documented hepatic
                  involvement with lymphoma

               -  Serum creatinine clearance ≥30 ml/min

               -  Absolute neutrophil count (ANC) ≥1000/μL (unless documented bone marrow
                  involvement with lymphoma)

               -  Platelet count ≥50,000/μL (unless documented bone marrow involvement with
                  lymphoma)

          -  At least 6 weeks from autologous stem cell transplantation

          -  At least 3 months from allogeneic stem cell transplantation and off immunosuppression
             and no evidence of graft versus host disease (GVHD)

          -  Previous treatment with brentuximab vedotin will be allowed if it was done 6 months
             prior to enrollment and patient was not refractory

          -  Measurable disease ≥1.5 cm seen on computed tomography (CT) scan and
             Fluorodeoxyglucose (FDG) avid disease on positron emission Tomography (PET) scan.
             Splenomegaly measuring >12 cm, if attributed to TCL and/or positive bone marrow
             involvement with lymphoma are also eligible.

          -  Females of childbearing potential must have a negative serum or urine pregnancy test
             result within 7 days prior to the first dose of study treatment. Women of
             child-bearing age must agree to use an effective contraception method during the study
             and for at least 6 months following the last dose of study drug.

          -  Males who have partners of childbearing potential must agree to use an effective
             contraceptive method during the study and for 6 months following the last dose of
             study drug.

          -  Subjects must have the ability to understand and the willingness to sign a written
             informed consent document

        Exclusion Criteria:

          -  Anaplastic large cell lymphoma (ALCL) both alk positive and negative

          -  Cutaneous T cell lymphomas except transformed Mycosis fungoides (MF)

          -  Prior treatment with Brentuximab in the last 6 months or previously refractory to
             Brentuximab Vedotin (BV) or had progressive disease (PD) while on BV

          -  Pregnancy or breast feeding women

          -  Prior malignancy within the past 3 years except non melanoma skin cancer or other
             localized cancer treated with curative intent

          -  Presence of grade >2 peripheral neuropathy or patients with the demyelinating form of
             Charcot-Marie-Tooth syndrome.

          -  Presence of central nervous system (CNS) involvement requiring active treatment

          -  History of progressive multifocal leukoencephalopathy (PML)

          -  Myocardial infarction within the past 6 months

          -  Patients with the following medical conditions that could affect their participation
             in the study:

               -  any active acute or chronic or uncontrolled infection

               -  liver disease including history of viral hepatitis B or C, evidence of cirrhosis,
                  chronic active or persistent hepatitis

               -  a known history of HIV

               -  symptomatic cardiac disease, including congestive heart failure, coronary artery
                  disease, and arrhythmias

          -  Prior hypersensitivity to any component in the ADC formulation

          -  Treatment with chemotherapy or investigational agents within 2 weeks of start of study
             treatment
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Deepa Jagadeesh, MD, MPH, 1-866-223-8100, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02588651

Organization ID

CASE1415


Responsible Party

Sponsor-Investigator

Study Sponsor

Deepa Jagadeesh


Study Sponsor

Deepa Jagadeesh, MD, MPH, Principal Investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center


Verification Date

June 2021