Clinical Trials /

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

NCT04334174

Description:

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.

Related Conditions:
  • Adult T-Cell Leukemia/Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Anaplastic Large Cell Lymphoma, ALK-Negative
  • Angioimmunoblastic T-Cell Lymphoma
  • Enteropathy-Associated T-Cell Lymphoma
  • Hepatosplenic T-Cell Lymphoma
  • Peripheral T-Cell Lymphoma, Not Otherwise Specified
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04334174

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: IIT-2019-BRENTICON-T
  • NCT ID: NCT04334174

Conditions

  • T Cell Lymphoma

Interventions

DrugSynonymsArms
Brentuximab VedotinAdcetris, SGN-35Single Arm

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Single ArmExperimentalBrentuximab 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.
  • Brentuximab Vedotin

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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

Measure: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.
Safety Issue:
Description:Comparing statistical survival rates with survival rates of study participants.
Measure:The number of adverse events or laboratory abnormalities
Time Frame:30 days
Safety Issue:
Description:Monitoring the number of adverse events or laboratory abnormalities using the CTCAEv5 as reference.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Siddhartha Ganguly

Trial Keywords

  • CD30 Positive Mature T Cell Lymphoma

Last Updated

June 11, 2020