The trial aims to test whether PET-CT scanning assessing the initial response to chemotherapy can be used to guide subsequent treatment

Phase 1

• Conditions: 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: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-14
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

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

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 900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

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).

Study & Design

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