CompletedPhase 2

Study on the Role of Brentuximab Vedotin as Single Agent in the Treatment of Relapsed/Refractory CD30+ PTCL Patients

Italy25 participantsStarted 2015-09-21

Plain-language summary

This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of Brentuximab Vedotin (BV) as a single agent in relapsed/refractory CD30+ PTCL patients.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed written informed consent. * Males and females ≥18 and ≤75 years at the time of enrolment. * 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. * Histologically confirmed CD30+ PTCL. * Availability of histological material for central review and pathobiological studies. * Failed at least one prior systemic antilymphoma therapy. * Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 at study entry. * 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). * Hematology values within the following limits: * Absolute neutrophil count (ANC) ≥ 1500/mm3 independent of growth factor support. * Platelets ≥75,000/mm3 or ≥50,000/mm3 if bone marrow involvement is independent of transfusion support. * Hemoglobin level ≥8 g/dL. * Biochemical values within the following limits: * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3 x upper limit of normal (ULN). * Total bilirubin \< 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin). * Serum creatinine ≤ 2 x ULN. * Serum albumin ≥ 3 g/dL. * Women of ch…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

overall objective response rate (ORR)

Timeframe: 1 year

Trial details

NCT IDNCT02497131

SponsorFondazione Italiana Linfomi - ETS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-24

View on ClinicalTrials.gov More Lymphatic Diseases trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.