Phase II clinical trial: Can a new drug help treat relapsed or refractory (not responding to treatment) ALK+ anaplastic large cell lymphoma?

Project title: NIVO-ALCL -Phase II trial of nivolumab for paediatric and adult relapsing/refractory ALK+ anaplastic large cell lymphoma, for evaluation of response in patients with progressive disease (Cohort 1) or as consolidative immunotherapy in patients in complete remission after relapse (Cohort 2)

Funded by The Little Princess Trust and administered by CCLG
Lead investigators: Dr Amos Burke, Cambridge University Hospitals NHS Foundation Trust and Prof Pam Kearns, Cancer Research UK Clinical Trials Unit
Award: £89,882.94
Awarded August 2019

ALK+ anaplastic large cell lymphoma (ALCL) is a type of non-Hodgkin lymphoma (a type of blood cancer) which more commonly affects children and young people. Dr Burke and Professor Kearn’s project is a clinical trial which will test whether a new drug called Nivolumab can control ALK+ ALCL when it has come back after treatment with other chemotherapy, or where the patient has failed to respond to any treatment at all. They will study the drug in children and some adults who are affected by this rare form of cancer.

Currently, there is no standardised plan for follow-on treatment for ALK+ALCL when it does not respond to first-line therapy. Therefore some patients end up needing a bone marrow transplant to try and cure their disease. Nivolumab is an exciting new therapy option which is hoped to improve life expectancy of patients with this particular form of lymphoma. It is a drug that allows the patient’s own immune system to recognise a cancer by blocking the messages that the cancer is using to hide from the immune system. The trial will study two cohorts of patients in order to answer the following questions about how well Nivolumab works: 

  1. (Cohort 1) How well can Nivolumab control ALK+ALCL when patients have failed to respond to previous treatment and what is the best control that can be seen in the first 6 months of treatment with this drug?
  2. (Cohort 2) Can Nivolumab treatment be used instead of bone marrow transplantation for patients who would be recommended to have this as part of their treatment?

In both groups of patients, Nivolumab is given by an injection over 30 to 60 minutes every 2 weeks to begin with and depending on how well they respond to the treatment this may change to every 4 weeks. The length of treatment with Nivolumab on the trial will be a maximum of 24 months.

This is an international study and will include 20 cancer centres across Europe. The UK centre is in Cambridge (Addenbrookes Hospital NHS) and UK patients eligible to be involved in the clinical trial will be referred there from centres throughout the UK for this treatment.