Medical condition under investigation is Hodgkin Lymphoma, which is a cancer of the lymphatic system. It is usually treated with either chemotherapy or radiotherapy or a combination of both. MedDRA version: 18.1 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma System Organ Class: 100000004864
Conditions
Interventions
Product Name: Doxorubicin
Pharmaceutical Form: Injection
INN or Proposed INN: DOXORUBICIN
CAS Number: 23214928
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed classical Hodgkin lymphoma according to the current WHO Classification. All histology will be reviewed centrally. 2. Stage IIB, III or IV, or stage IIA with adverse features, defined as: - bulk mediastinal disease, defined as maximal diameter of mass >0.33 of the internal thoracic diameter at D5/6 on PA chest X-ray, or outside the mediastinum, lymph node or lymph node mass greater than 10cm in diameter - >=2 extranodal sites of disease - other poor risk features as a result of which it is considered necessary to treat with full course combination chemotherapy 3. No previous treatment for Hodgkin Lymphoma 4. Adequate performance status (WHO 0-3); bone marrow function; renal and liver function. 5. Patients with a significant history of ischaemic heart disease or hypertension must have a left ventricular ejection fraction (LVEF) greater than or equal to 50%. 6. Written, informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Poorly-controlled diabetes mellitus, or other serious medical conditions 2. Current pregnancy or lactation 3. Central nervous system or meningeal involvement by the lymphoma. Neurological contra-indication to chemotherapy (e.g. pre-existing neuropathy). 4. Significant lung disease with abnormal lung function tests (DLCO >25% below predicted) not attributable to lymphoma 5. Known serology for HIV, Hepatitis B or Hepatitis C (but no requirement for routine testing in the absence of risk factors).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The 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. ;Secondary Objective: Overall survival and Toxicity ;Primary end point(s): The specific aim of this research is to prospectively evaluate the use of FDG-PET to permit early assessment of tumour response. This will allow selective escalation of therapy for those with a poor prognosis, and test de-escalation of treatment to minimise long-term toxicity for those with a good initial response. All patients will receive 2 courses of ABVD chemotherapy and then undergo a FDG-PET scan. Patients who become PET negative will be randomised between ABVD and AVD, the omission of bleomycin aiming to reduce lung toxicity whilst achieving an equivalent outcome. Those who remain PET positive will undergo treatment escalation with the BEACOPP-14 regimen, attempting to improve remission rates thereby.;Timepoint(s) of evaluation of this end point: 3 cycle response End of treatment response During follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival Toxicity, both acute (during the treatment) Long-term until 5 years from randomisation;Timepoint(s) of evaluation of this end point: During treatment and follow up | — |
Countries
Australia, Denmark, Ireland, Italy, New Zealand, Norway, Sweden, United Kingdom
Contacts
Public ContactRATHL Trial Coordinator
Cancer Research UK & UCL Cancer Trials Centre
Outcome results
None listed