Study of Brentuximab Vedotin as Therapy After Autologous Stem Cell Transplant in Cluster of Differentiation Antigen 30 (CD30) Positive Peripheral TCell Lymphomas

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Brief Title

Study of Brentuximab Vedotin as Therapy After Autologous Stem Cell Transplant in Cluster of Differentiation Antigen 30 (CD30) Positive Peripheral TCell Lymphomas

Official Title

A Phase II Single Arm Proof of Concept, Safety, Efficacy, Multicenter Study of Brentuximab Vedotin as Consolidation Therapy After Autologous Stem Cell Transplant in CD30 Expressing Peripheral T Cell Lymphomas

Brief Summary

      For participants with CD30 positive Mature T-cell lymphomas who have received brentuximab
      vedotin, cyclophosphamide, doxorubicin, and prednisone (A-CHP) as induction (4 to 6 cycles)
      and achieved complete response (CR) or chemo-sensitive partial response (PR) and deemed
      suitable for autologous stem cell transplant (ASCT) as consolidation, the investigators
      propose to add brentuximab vedotin after ASCT.

      There is currently no standard of care treatment to prevent relapse after upfront treatment
      or ASCT for CD30-positive peripheral T-cell lymphoma's (PTCL)s. An agent that could improve
      outcomes in this population would be a major contribution to the field and is likely to be
      practice changing. Therefore, in addition to studying the anti-lymphoma activity of A-CHP as
      induction therapy, for participants who respond to induction the investigators propose to add
      brentuximab vedotin consolidation after ASCT in participants treated with consolidative
      upfront ASCT.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of participants who experience safety related issues caused by study treatment: CTCAEv5

Secondary Outcome

 Progression Free Survival

Condition

T Cell Lymphoma

Intervention

Brentuximab Vedotin

Study Arms / Comparison Groups

 Single Arm
Description:  Brentuximab vedotin (SGN-35), intravenous infusion, 1.8 milligrams (mg) per kilogram (kg), day one of each twenty- one day cycle with a total of ten cycles planned.

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

36

Start Date

May 29, 2020

Completion Date

April 2024

Primary Completion Date

April 2023

Eligibility Criteria

        Inclusion Criteria:

          -  A-CHP for 6 cycles. First cycle may be cyclophosphamide, doxorubicin, vincristine, and
             prednisone (CHOP)- based if already planned and then 5 cycles of A-CHP.

          -  Performance status of 0-2.

          -  Participants with CD30 positive mature T- cell lymphomas who have received A-CHP as
             induction and achieved complete response (CR) or chemo- sensitive partial response
             (PR) and deemed suitable for ASCT as consolidation.

          -  Eligible disease types:

               -  Anaplastic lymphoma kinase (ALK)- negative systemic Anaplastic large-cell
                  lymphoma (sALCL)

               -  Peripheral T-cell lymphoma- not otherwise specified (PTCL-NOS)

               -  Angioimmunoblastic T-cell lymphoma (AITL)

               -  Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be
                  positive for human T cell leukemia virus 1)

               -  Enteropathy-associated T-cell lymphoma (EATL)

               -  Hepatosplenic T-cell lymphoma (HSTCL)

          -  Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and
             measurable disease by Computed tomography (CT), as assessed by the site radiologist.

          -  Adequate organ function.

        Exclusion Criteria:

          -  Enrolled in any other treatment clinical trial.

          -  Is breastfeeding.

          -  Active severe or medically significant or higher viral, bacterial, or fungal infection
             within 2 weeks prior to the first dose of study treatment.

          -  Has human immunodeficiency virus (HIV) infection, hepatitis B surface antigen-positive
             status, or known or suspected active hepatitis C infection.

          -  Left ventricular ejection fraction (LVEF) less than 45% or symptomatic cardiac
             disease, or myocardial infarction within the past 6 months.

          -  Previous treatment with complete cumulative doses of doxorubicin or other
             anthracyclines.

          -  Baseline, moderate, peripheral neuropathy or patients with the demyelinating form of
             Charcot-Marie-Tooth syndrome.

          -  Post auto or allo stem cell transplant (SCT).

          -  Cerebral/meningeal disease related to the underlying malignancy.

          -  History of progressive multifocal leukoencephalopathy (PML).

          -  Current diagnosis of any of the following:

               -  Primary cutaneous CD30-positive T-cell lymphoproliferative disorders and
                  lymphomas. Cutaneous ALCL with tumor spread outside of the skin and to lymph
                  nodes away from the primary site are eligible.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sid Ganguly, MD, 9135883671, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04334174

Organization ID

IIT-2019-BRENTICON-T


Responsible Party

Sponsor-Investigator

Study Sponsor

Siddhartha Ganguly

Collaborators

 Seagen Inc.

Study Sponsor

Sid Ganguly, MD, Principal Investigator, The University of Kansas


Verification Date

June 2020