A randomised Phase III trial to assess response adapted therapy using FDG-PET imaging in patients with newly diagnosed, advanced Hodgkin Lymphoma
Description
Design:
RATHL is a multi-centre randomised trial comparing treatment outcome for patients with advanced Hodgkin lymphoma, using FDG-PET imaging after 2 cycles of ABVD to determine response and subsequent management.
Treatment:
All patients will receive 2 cycles of ABVD before randomisation. Patients then have a PET-CT scan. Patients with a negative result are randomised to receive either a further 4 cycles of ABVD or 4 cycles of AVD. Patients with a positive result will receive either 4 cycles of BEACOPP-14 or 3 cycles of BEACOPP escalated (determined by the site at the beginning of the trial). Patients who had a positive result at the 2nd PET-CT scan will have another PET-CT scan. Patients with a negative result will receive a further 2 cycles of BEACOPP-14 or 1 cycle of BEACOPP escalated. Patients with a positive result with receive radiotherapy or a salvage therapy determined by the investigator. Patients are then followed up until death.
Key inclusion/exclusion criteria:
Patients must be 18 or above and have histologically proven classical Hodgkin Lymphoma. Patient must have stage IIB-IV disease or stage IIA with adverse features. Patients ECOG performance status must be 0-3 and they must have adequate bone marrow function and neutrophils. Patients can’t have CNS involvement, HIV or serological evidence of active Hepatitis B or Hepatitis C infection. Patients can’t have a cardiac contraindication to doxorubicin or neurological contraindication to chemotherapy.
Duration of recruitment:
3-4 years
Aim
The overall aim of this study is to evaluate prospectively the role of FDG-PET imaging after 2 cycles of ABVD chemotherapy in determining response assessment and subsequent management decisions for patients receiving first-line treatment for advanced Hodgkin lymphoma.