NCRI Lymphoma and Radiotherapy Group: 18-30

A PHASE II STUDY EVALUATING THE TOXICITY AND EFFICACY OF A GERMAN PAEDIATRIC HODGKIN’S LYMPHOMA PROTOCOL (HD95) IN YOUNG ADULTS (AGED 18-30 YEARS) WITH HODGKIN’S LYMPHOMA

This is a phase II, non-randomised, open-label, single arm trial conducted throughout the UK. 45 young adults aged 18-30 years will be recruited to the study and allocated to a Treatment Group according to the stage of their disease to determine which chemotherapy regimen they will receive. They will receive 2-6 courses of chemotherapy according to their disease and stage. Modified involved field radiotherapy (‘involved site radiotherapy’) will be given to sites of initial disease depending on the initial stage of the disease and the response to chemotherapy. The study will be conducted over a 2 year period.

If neurotoxicity is within acceptable limits the next step will be to run the study in an older cohort of patients aged 31-45 years. If this is tolerated well consideration will be given to test the regimen in a cohort of older patients. Once the age groups which can tolerate this regimen has been determined the plan will be to initiate a randomised phase 3 study comparing this protocol with the current standard adult protocol.

This study is co-ordinated under the auspices of Cancer Research UK and the NCRI Radiotherapy and Lymphoma Clinical Studies Group.

Chief Investigator:

Dr Kirit Ardeshna

Consultant Haematologist

University College Hospital London NHS Trust

250 Euston Road

London NW1 2PG

Quality Assurance Physicist:

Patty Díez

Clinical Physics

Mount Vernon Hospital

Rickmansworth Road