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

Primary Purpose

T Cell Lymphoma

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brentuximab Vedotin
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T Cell Lymphoma focused on measuring CD30 Positive Mature T Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Kansas Cancer Center, Westwood Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progression Free Survival
Comparing statistical survival rates with survival rates of study participants.
The number of adverse events or laboratory abnormalities
Monitoring the number of adverse events or laboratory abnormalities using the CTCAEv5 as reference.

Full Information

First Posted
March 20, 2020
Last Updated
February 1, 2023
Sponsor
University of Kansas Medical Center
Collaborators
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04334174
Brief Title
Study of Brentuximab Vedotin as Therapy After Autologous Stem Cell Transplant in Cluster of Differentiation Antigen 30 (CD30) Positive Peripheral TCell Lymphomas
Acronym
BRENTICON-T
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
accrual not met
Study Start Date
May 29, 2020 (Actual)
Primary Completion Date
December 14, 2022 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Seagen Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T Cell Lymphoma
Keywords
CD30 Positive Mature T Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
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.
Intervention Type
Drug
Intervention Name(s)
Brentuximab Vedotin
Other Intervention Name(s)
Adcetris, SGN-35
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants who experience safety related issues caused by study treatment: CTCAEv5
Description
Using the Common Terminology Criteria for Adverse Events version 5 (CTCAEv5) to evaluate participants reaction to treatment.
Time Frame
Up to three years
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
Comparing statistical survival rates with survival rates of study participants.
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.
Title
The number of adverse events or laboratory abnormalities
Description
Monitoring the number of adverse events or laboratory abnormalities using the CTCAEv5 as reference.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sid Ganguly, MD
Organizational Affiliation
The University of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Kansas Cancer Center, Westwood Campus
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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