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Brentuximab Vedotin for the Treatment of CD30 Positive T-Cell Lymphomas in Patients after Stem Cell Transplant, BRENTICON-T Study

Trial Status: Active

This phase II trial studies the side effects and how well brentuximab vedotin works in treating patients with CD30 positive lymphoma who have undergone a stem cell transplant. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Brentuximab vedotin may improve outcomes in CD30 positive lymphoma patients who have undergone a stem cell transplant.

Inclusion Criteria

  • Ability of participant OR legally authorized representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
  • Prior therapy: Brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone (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
  • Eastern Cooperative Oncology Group (ECOG) performance status = 0-2
  • Patients with CD30-expressive mature T-cell lymphomas per the Revised European-American Lymphoma World Health Organization (WHO) 2008 classification by local assessment who have received A-CHP as induction and achieved complete remission (CR) or chemo-sensitive partial remission (PR) and deemed suitable for ASCT as consolidation
  • N.B: CD30 expression > or equal to 1% lymphoid infiltrate
  • Eligible histologies are limited to the following: * 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
  • Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and measurable disease by computed tomography (CT), as assessed by the site radiologist
  • Leukocytes >= 1.5 K/UL
  • Absolute neutrophil count >= 1.0 K/UL
  • Platelets >= 50 K/UL
  • Serum creatinine clearance > 40 mL/min
  • Total bilirubin =< 1.5 x ULN
  • Aspartate aminotransferase and alanine aminotransferase =< 2.5 x upper limit of normal (ULN)
  • Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use the forms of contraception for the duration of study participation, and for 6 months following completion of therapy

Exclusion Criteria

  • Simultaneously enrolled in any therapeutic clinical trial
  • Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
  • Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
  • Is breastfeeding
  • Has a known allergic reactions to any excipient contained in the study drug formulation
  • Active grade 3 (per the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 5.0) 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 (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), or myocardial infarction within the past 6 months
  • Previous treatment with complete cumulative doses of doxorubicin or other anthracyclines
  • Baseline peripheral neuropathy > grade 2 (per the NCI CTCAE, version 5.0) or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
  • Post auto stem cell transplant (SCT)
  • Post allo SCT
  • Resistant or progressive disease on A-CHP
  • 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 extracutaneous tumor spread beyond locoregional lymph nodes is eligible (previous single-agent treatment to address cutaneous and locoregional disease is permissible) * Mycosis fungoides (MF), including transformed MF * ALK positive systemic ALCL

Kansas

Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE
Contact: Siddhartha Ganguly
Phone: 913-588-6030

PRIMARY OBJECTIVES:

I. Safety of study treatment:

Ia. Rates of serious adverse events (SAEs).

Ib. Treatment discontinuations.

Ic. Grade >= 3 toxicities.

Id. Treatment-related death.

SECONDARY OBJECTIVES:

I. To determine the progression free survival (PFS).

II. Incidence of adverse events or laboratory abnormalities.

OUTLINE:

Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for 10 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, 6, 9, and 12 months, and then every 6 months for 2 years.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
University of Kansas Hospital-Westwood Cancer Center

Principal Investigator
Siddhartha Ganguly

  • Primary ID IIT-2019-BRENTICON-T
  • Secondary IDs NCI-2020-03632
  • Clinicaltrials.gov ID NCT04334174