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

NCT04334174 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: IIT-2019-BRENTICON-T
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

T Cell Lymphoma

Keywords

CD30 Positive Mature T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to three years

Secondary Outcomes (2)

• Progression Free Survival

  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

  30 days

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Interventions

Brentuximab Vedotin DRUG

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.

Also known as: Adcetris, SGN-35

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Seagen Inc.: collaborator

Study Sites (1)

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, 66205, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Sid Ganguly, MD

  The University of Kansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: April 6, 2020
• Study Start: May 29, 2020
• Primary Completion: December 14, 2022
• Study Completion: February 1, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-02

Locations

US (1)