A Randomised Phase III Trial to assess response adapted therapy using FDG-PET imaging in patients with newly diagnosed, advanced Hodgkin Lymphoma - RATHL Trial

• Conditions: Advanced Hodgkin Lymphoma; MedDRA version: 9.1Level: LLTClassification code 10020328Term: Hodgkin's lymphoma

• Registration Number: EUCTR2007-006064-30-IE
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-06
• Last Update Posted: 31 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

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.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
3. No previous chemotherapy, radiotherapy or other investigational drug for HL.
4. Performance status 0-3 (Appendix 6).
5. 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
6. 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.
7. Patients with a significant history of ischaemic heart disease or hypertension must have an acceptable left ventricular ejection fraction (LVEF) =50%.
8. Lung function tests showing diffusion capacity within 25% of normal predicted value for the patient.
9. Life expectancy > 3 months.
10. Adequate contraceptive precautions for all patients of childbearing potential
11. Written, informed consent.
12. Access to PET-CT scanning

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Poorly controlled Diabetes mellitus
2. Other concurrent uncontrolled medical condition
3. Current pregnancy or lactation
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified