Purpose of the trial
The aims of the trial are:
- Evaluate the occurrence of serious adverse events (SAEs) and specified adverse events of special interest (AESI), both serious and non-serious in routine practice with brentuximab vedotin in patients actively treated for CD30+ HL or anaplastic large cell lymphoma (sALCL) which has either come back after treatment or is resistant to previous treatment; and
- Identify and describe potential risk factors for peripheral neuropathy in patients treated with brentuximab vedotin with a diagnosis of CD30+ HL or sALCL which has come back after treatment or is resistant to previous treatment
This study looks at the safety of brentuximab vedotin treatment in patients who have been diagnosed with CD30+ Hodgkin lymphoma or anaplastic large cell lymphoma (sALCL) which has returned after treatment or is resistant to previous treatment received. The study will target the enrollment of approximately 500 patients (at least 50 of whom have a diagnosis of sALCL), who are treated with brentuximab vedotin at approximately 75-100 sites in Europe and potentially other countries outside of Europe. Patients will be enrolled over an approximate 3-year enrollment period and the total study duration will be five years from the date of first patient enrolled. Patients already being treated with brentuximab vedotin at the time of enrollment will be considered to be retrospectively enrolled for purposes of analysis and inclusion in the PASS.
Who can enter
The trial team can advise you whether you are suitable for this trial and whether any other conditions or treatments you have or have had prevent you from entering the trial.
You may be able to enter if:
- You are aged 18 years at enrolment
- You have a clinical diagnosis (with histologic confirmation) of CD 30+ HL or sALCL which is either resistant to treatment or has returned following treatment
- You have been planned to start or if you are already receiving single agent therapy with brentuximab vedotin as part of routine clinical care
- You are willing and able to provide informed consent
You won’t be able to enter if:
- You are involved in concurrent participation in an interventional clinical study
- You have a diagnosis of primary cutaneous ALCL, unless the disease has transformed to systemic ALCL
To find out more get in touch with The Lymphoma Group for more information.