Phase II study on the role of brentuximab vedotin as single agent in the treatment of relapsed/refractory CD30 positive peripheral T cell lymphoma (PTCL) patients
- Conditions
- RELAPSED/REFRACTORY CD30 POSITIVE PERIPHERAL T CELL LYMPHOMA (PTCL)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2013-003946-17-IT
- Lead Sponsor
- Fondazione Italiana Linfomi ONLUS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 25
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:
oAbsolute neutrophil count (ANC) = 1500/mm3 independent of growth factor support.
oPlatelets =75,000/mm3 or =50,000/mm3 if bone marrow involvement is independent of transfusion support.
oHemoglobin level =8 g/dL.
10.Biochemical values within the following limits:
oAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 x upper limit of normal (ULN).
oTotal bilirubin < 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin).
oSerum creatinine = 2 x ULN.
oSerum albumin = 3 g/dL.
11.Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of receiving study medication.
12.WOCBP must agree to use effective contraception, defined as oral contraceptives, double barrier method or practice true abstinence from sexual intercourse during the study and for 6 months after the last dose of study drug.
13.Male subjects and their female partners of childbearing potential must be willing to use an appropriate method of contraception or practice true abstinence from sexual intercourse during the study and for 6 months after the last dose of study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
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
oMyocardial infarction within 2 years from enrollment
oNew York Heart Association (NYHA) Class III or IV heart failure
oEvidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
oRecent 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>• To assess survival<br>• To assess the safety and tolerability of BV<br>• 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 Outcome Measures
Name Time Method Secondary end point(s): • Duration of response <br>• Complete remission (CR) rate <br>• Progression-free survival (PFS) at one year<br>• Overall survival (OS) at one year<br>• Type, incidence, severity, seriousness, and relatedness of adverse events, and laboratory abnormalities;Timepoint(s) of evaluation of this end point: 1 year