RATHL
Trial overview
A RANDOMISED PHASE III TRIAL TO
ASSESS RESPONSE ADAPTED
THERAPY USING FDG-PET IMAGING
IN PATIENTS WITH NEWLY
DIAGNOSED, ADVANCED HODGKIN
LYMPHOMA
Inclusion criteria
1. Histologically confirmed classical Hodgkin lymphoma (HL) according to the current
World Health Organisation Classification (nodular sclerosis, mixed cellularity,
lymphocyte rich, lymphocyte depleted). All histology will be reviewed by a central
pathology panel for the group concerned.
2. Aged 18 or above
3. Clinical stage IIB, IIIA, IIIB or IV, or Clinical stage IIA with adverse features:
• bulk mediastinal disease, defined as maximal transverse diameter of mass
>0.33 of the internal thoracic diameter at D5/6 interspace on routine chest X-
ray
• outside the mediastinum, lymph node or lymph node mass greater than 10cm in
diameter
• more than two sites of disease
• other poor risk features as a result of which it is considered necessary to treat
with full course combination chemotherapy
4. No previous chemotherapy, radiotherapy or other investigational drug for HL.
5. Performance status 0-3 (Appendix 6).
6. Adequate bone marrow function with platelets > 100x109/l; neutrophils >
1.5x109/l at the time of study entry unless lower numbers are attributed to bone
marrow infiltration by lymphoma
7. Serum creatinine less than 150% of the upper limit of normal, serum bilirubin less
than twice the upper limit of normal and transaminases < 2.5× upper limit of
normal unless attributed to lymphoma.
8. Patients with a significant history of ischaemic heart disease or hypertension must
have an acceptable left ventricular ejection fraction (LVEF) =50%.
9. Lung function tests showing diffusion capacity within 25% of normal predicted
value for the patient.
10. Life expectancy > 3 months.
11. All patients of childbearing potential are willing to use adequate contraceptive
precautions.
12. Written, informed consent.
13. Access to PET-CT scanning
Exclusion criteria
1. Poorly controlled Diabetes mellitus
2. Other concurrent uncontrolled medical condition
3. Pregnant or lactating
4. Central nervous system or meningeal involvement by the lymphoma
5. Cardiac contra-indication to doxorubicin: abnormal contractility on
echocardiography or nuclear medicine examination (MUGA).
6. Neurological contra-indication to chemotherapy (e.g. pre-existing neuropathy).
7. General status that does not allow the administration of a full course of
chemotherapy according to the investigator.
8. Previous history of active malignant disease other than fully excised basal or
squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix in
the last 10 years.
9. Known positive serology for HIV, Hepatitis B or Hepatitis C (but no requirement for
routine testing in the absence of risk factors).
10. Medical or psychiatric conditions that compromise the patient’s ability to give
informed consent.
Contact details
Other trials currently active for Classical Hodgkin Lymphoma
A randomised phase III trial to determine the role of FDG-P imaging in clinical stages IA/IIA Hodgkins disease.
To evaluate the efficacy and toxicity of VEPEMB in a phase II study in older patients with Hodgkins Lymphoma (HL). A number of older patients with HL fail to enter clinical trials as they are "not fit" for multiple drug chemotherapy. This study will aim to include all pathologically eligible patients in participating centres in order to provide a clearer overall clinical picture of this disease, whether or not they undergo protocol chemotherapy.