Outcomes post Brentuximab for Relapsed Anaplastic Large Cell Lymphoma
Research type
Research Study
Full title
Real World Outcomes for ALK positive anaplastic large cell lymphoma (ALK+ve ALCL) and ALK negative anaplastic large cell lymphoma (ALK-ve ALCL) following treatment with Brentuximab Vedotin in England
IRAS ID
282791
Contact name
Maria Koufali
Contact email
Sponsor organisation
R&I, Nottingham University Hospitals NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Sumary
Adult patients with systemic anaplastic large cell lymphoma (ALCL) have a cure rate of only ~40% with first line therapy. Those patients who relapse traditionally only survived a few months.
Brentuximab vedotin has been available to patients in England through the Cancer Drugs Fund since April 2013 and was NICE approved in October 2014 for relapsed or refractory systemic anaplastic large cell lymphoma. Brentuximab vedotin is extremely expensive and it is important to know exactly how effective it has been.
Using Public Health England depersonalised data we wish to collect data on outcomes for patients over 18 years old with relapsed or refractory systemic ALK positive anaplastic large cell lymphoma (ALK+ve ALCL) and ALK negative anaplastic large cell lymphoma (ALK-ve ALCL) diagnosed in England between 1st April 2013 to 31st December 2018 following treatment with brentuximab vedotin.
We aim to
1. Describe and analyse baseline (anonymised) demographics
2. Describe and analyse delivered lines of therapies received prior to BV
3. Assess the median number of cycles of BV received by patients.
4. Progression free survival
5. Time to next treatment
6. Describe and analyse the number and type of stem cell transplants performed following BV.
7. Describe the impact on overall survival of autologous or allogeneic transplants following BV compared to those not transplanted.Summary of Results
Anaplastic large cell lymphoma (ALCL) accounts for only 2% of all adult lymphoma. Outcomes for ALCL have been revolutionised by a new treatment called brentuximab vedotin (BV) but outcome data is limited as the disease is rare BV and only small trials have been reported. We requested Public Health England data on all cases of relapsed ALCL between 2013-2018 and outcomes following BV treatment. We identified 127 patients with a average age of 60 years. Almost half the patients remained in remission after BV on its own, and only a small number had a stem cell transplant afterwards. We reported excellent survival following treatment with BV in a real-world setting, comparable with previous clinical trial data.REC name
London - London Bridge Research Ethics Committee
REC reference
20/LO/0803
Date of REC Opinion
3 Jun 2020
REC opinion
Favourable Opinion