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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2023

Interventions

  • Drug: Brentuximab Vedotin
    • Brentuximab Vedotin will be dosed at 1.8 milligram (mg) per (/) kilogram (Kg) of participants body weight will be infused intravenously every three weeks for up to ten infusions.

Arms, Groups and Cohorts

  • Experimental: Single Arm
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants who experience safety related issues caused by study treatment: CTCAEv5
    • Time Frame: Up to three years
    • Using the Common Terminology Criteria for Adverse Events version 5 (CTCAEv5) to evaluate participants reaction to treatment.

Secondary Measures

  • Progression Free Survival
    • Time Frame: From date of randomization until the date of first documented progression or to death due to any cause, whichever comes first, up to 3 years.
    • Comparing statistical survival rates with survival rates of study participants.
  • The number of adverse events or laboratory abnormalities
    • Time Frame: 30 days
    • Monitoring the number of adverse events or laboratory abnormalities using the CTCAEv5 as reference.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Siddhartha Ganguly
  • Collaborator
    • Seattle Genetics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Siddhartha Ganguly, Professor of Medicine Hematology – University of Kansas Medical Center
  • Overall Official(s)
    • Sid Ganguly, MD, Principal Investigator, The University of Kansas
  • Overall Contact(s)
    • KUCC Navigator, 9135883671, KUCC_Navigation@kumc.edu

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