RELAPSED/REFRACTORY CD30 POSITIVE PERIPHERAL T CELL LYMPHOMA (PTCL)
Conditions
Interventions
Trade Name: Brentuximab Vedotin
Product Name: Brentuximab vedotin
Pharmaceutical Form: Infusion
INN or Proposed INN: Brentuximab Vedotin
CAS Number: 914088-09-8
Other descriptive name: SGN-35
Concentr
Sponsors
Fondazione Italiana Linfomi ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent. 2. Males and females =18 years at the time of enrolment. 3. Histologically confirmed diagnosis of PTCL (PTCL-not otherwise specified [PTCL-NOS], angioimmunoblastic T cell lymphoma [AILT] and transformed mycosis fungoides) according to World Health Organization (2008) classification. 4. Histologically confirmed CD30+ PTCL. 5. Availability of histological material for central review and pathobiological studies. 6. Failed or intolerant of at least one prior systemic antilymphoma therapy. 7. Eastern Cooperative Oncology Group (ECOG) performance status score of = 1 at study entry. 8. At least one site of disease measurable in two dimensions by computed tomography. Both nodal and extranodal disease will be considered (lymphnodes must have long axis of 1.5 cm regardless of short axis or long axis 1.1 to 1.5 cm and short axis >1.0 cm). 9. Hematology values within the following limits: o Absolute neutrophil count (ANC) = 1500/mm3 independent of growth factor support. o Platelets =75,000/mm3 or =50,000/mm3 if bone marrow involvement is independent of transfusion support. o Hemoglobin level =8 g/dL. 10. Biochemical values within the following limits: o Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Diagnosis of CTCL, ALCL, mycosis fungoides or Sezary Syndrome. 2. CD30 expression < 10 % as measured by IHC 3. Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment. 4. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin. 5. Any serious active disease or co-morbid medical condition (according to investigator's decision). 6. Prior history of malignancies other than lymphoma (except for a history of a complete resection for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for = 3 years. 7. Pre-existing peripheral neuropathy Grade =2. 8. Signs or symptoms of progressive multifocal leukoencephalopathy (PML). 9. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 10. Pregnant or lactating females or men or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study or a positive pregnancy test on Day 1 before first dose of study drug. 11. CNS disease (meningeal and/or brain involvement by lymphoma) or testicular involvement 12. History of clinically relevant liver or renal insufficiency; significant pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances. 13. Known history of any of the following cardiovascular conditions o Myocardial infarction within 2 years from enrollment o New York Heart Association (NYHA) Class III or IV heart failure o Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities o Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50% 14. Active opportunistic infection. 15. Known history of Human Immunodeficiency Virus (HIV) or Hepatitis C or active infection with Hepatitis B. 16. Prior allogeneic stem cell transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the antitumor efficacy of single-agent brentuximab vedotin (BV) (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in refractory/relapsed peripheral T-cell lymphoma (PTCL) patients.;Secondary Objective: • To assess duration of tumor control, including duration of response and progression-free survival • To assess survival • To assess the safety and tolerability of BV • To assess correlation between CD30 expression and response;Primary end point(s): The primary endpoint of this study is the overall objective response rate (ORR).;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Duration of response • Complete remission (CR) rate • Progression-free survival (PFS) at one year • Overall survival (OS) at one year • Type, incidence, severity, seriousness, and relatedness of adverse events, and laboratory abnormalities;Timepoint(s) of evaluation of this end point: 1 year | — |
Countries
Italy
Contacts
Public ContactSegreteria FIL
Segreteria Fondazione Italiana Linfomi Onlus
Outcome results
None listed