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

November 29, 2021 updated by: Marc Hoffmann, University of Kansas Medical Center

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66205
        • Recruiting
        • The University of Kansas Cancer Center, Westwood Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Adcetris, SGN-35

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

Seagen Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2020

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 6, 2020

Study Record Updates

Last Update Posted (Actual)

December 14, 2021

Last Update Submitted That Met QC Criteria

November 29, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2019-BRENTICON-T

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on T Cell Lymphoma

Clinical Trials on Brentuximab Vedotin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe