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Pilot Study of Brentuximab Vedotin in Relapsed/Refractory Peripheral T-Cell Lymphoma Expressing CD30 Receptor

18 Years
Not Enrolling
Peripheral T-Cell Lymphoma

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Trial Information

Pilot Study of Brentuximab Vedotin in Relapsed/Refractory Peripheral T-Cell Lymphoma Expressing CD30 Receptor

Inclusion Criteria:

- Confirmed diagnosis of PTCL expressing CD30 receptor. Diagnosis will be based on
identification of PTCL in biopsy specimens characterized by positivity for CD30
staining in the malignant cell population. Following PTCL subtypes will be eligible:
Peripheral T - cell lymphoma, not otherwise specified (NOS); Angioimmunoblastic
T-cell Lymphoma; Subcutaneous Panniculitis Like T-cell Lymphoma; Hepatosplenic
gamma/delta T cell Lymphoma; Extranodal natural killer (NK)T-cell Lymphoma, nasal
type; Enteropathy-associated T-cell lymphoma; Adult T-cell Leukemia/lymphoma; T-cell
prolymphocytic leukemia; Primary cutaneous gamma-delta T-cell lymphoma; Aggressive NK
cell leukemia; Epstein Barr Virus(EBV)-positive T-cell lymphoproliferative disorders
of childhood; Transformed mycosis fungoides who have progressed following treatment
with both methotrexate and bexarotene; Sezary syndrome

- Histology slides and pathology material must be available at the site for each
patient before enrollment in order to be sent to the Leading Institution of the study
for central pathology review and pharmacodynamic studies.

- Patients must have progressive, relapsed or refractory disease after: At least one
prior systemic anti-lymphoma regimen (chemotherapy or immunotherapy except for
transformed mycosis fungoides as described previously); Relapsed or failed autologous
or allogeneic stem cell transplant.

- Understand and voluntarily sign an Institutional Review Board (IRB) approved informed
consent form

- Must have at least one site of disease (index lesion) measurable in two dimensions by
computed tomography (CT)

- Patients with leukemic form of PTCL who will not have a measurable lesion in two
dimensions by CT scan, relapsed or refractory disease must be detected by
immunohistochemistry or flow cytometry and molecular clonality studies in bone marrow
or peripheral blood.

- At least 4 weeks since the last chemotherapy, radiation therapy, immunotherapy or any
investigational non-immunotherapy products

- Must meet the following criteria within 4 days before the first dose of study drug:

- Neutrophils ≥1,000/ul

- Hemoglobin ≥ 8 g/dL

- Platelets≥ 50.0x10^9 /L

- Total bilirubin ≤ 1.5 x upper normal limit, or ≤ 5 x upper normal limit if
documented hepatic involvement with lymphoma or history of Gilbert's Syndrome

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper
normal limit (≤ 5 x upper normal limit if documented hepatic involvement with

- Calculated creatinine clearance ≥ 40 mL/min/1.73 m^2 based on Cockcroft and
Gault method

- PT or International Normalization Ratio (INR), and Activated Partial
Thromboplastin Time (APTT) ≤ 1.5 x upper limit of normal unless patient is
receiving anticoagulants. If patient is on anticoagulation therapy, levels
should be within therapeutic range.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Negative pregnancy test for women of childbearing potential

- Recovered (≤ Grade 1 toxicity) from the reversible effects of prior
antineoplastic therapy

Exclusion Criteria:

- Any of the following cardiovascular conditions or values within 6 months before the
first dose of study drug: Myocardial infarction and the New York Heart Association
(NYHA) Class III or IV heart failure

- History of another primary malignancy not in remission for at least 3 years; except
adequately treated patients with completely resected in situ carcinoma, such as
nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous
intraepithelial lesion on Pap smear, or localized prostate cancer with
prostate-specific antigen (PSA) <1 ng/ml

- Known active cerebral/meningeal involvement with lymphoma. Asymptomatic patients with
previously treated and resolved central nervous system (CNS) lymphoma involvement are

- Prior administration of Brentuximab vedotin

- Corticosteroid monotherapy for lymphoma within 2 weeks of the first dose of study

- Any serious underlying medical condition that, in the opinion of the investigator or
medical monitor, would impair the ability to receive or tolerate the planned

- Known hypersensitivity to recombinant proteins, or any component contained in the
drug formulation

- Female patients who are lactating or have a positive serum pregnancy test during the
screening period

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate (ORR)

Outcome Description:

To evaluate the activity of Brentuximab vedotin in patients with relapsed/refractory Peripheral T cell Lymphoma (PTCL) expressing CD30 receptor. The ORR [complete response (CR)+ partial response (PR)] will be used as the primary endpoint to assess efficacy.The primary efficacy parameter is objective response rate, defined as the proportion of patients with complete response (CR) and partial response (PR). Follow-up assessments after cycle 16 will be done every 12 weeks for up to 24 months. Restaging imaging computed tomography (CT) scans will be repeated 12 and 24 months from the beginning of the follow-up period. Objective disease response (CR and PR) will be defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL). CR = Disappearance of all evidence of disease; PR = Regression of measurable disease and no new sites.

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Lubomir Sokol, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2013

Completion Date:

June 2017

Related Keywords:

  • Peripheral T-cell Lymphoma
  • Peripheral T-Cell Lymphoma (PTCL)
  • Relapsed
  • Refractory
  • CD30 Receptor
  • Large B-Cell Lymphoma
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612