HD 17 for intermediate stage Hodgkin lymphoma: randomised treatment based on results of FDG-PET sca

• Conditions: Hodgkin Lymphoma intermediate stage; MedDRA version: 14.1Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2007-005920-34-NL
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-16
• Last Update Posted: 25 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• Histologically proven Hodgkin lymphoma
• Newly diagnosed, no previous treatment
• Stage I, IIA with RF a-d; stage IIB with RF c, d
(a: large mediastinal mass, b: extranodal disease, c: high ESR, d: = 3 lymph node areas)
• Age: 18-60 years
• Patient had no previous treatment for HL
• Normal organ function (except HL-related);
• Life expectancy > 3 months.
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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Composite lymphoma
• Previous malignancy, prior chemotherapy or radiotherapy
• Concurrent diseases which preclude protocol treatment
• Pregnancy, lactation
• Non-compliance
• WHO activity index > 2
• Antiepileptic treatment
• Concurrent diseases which preclude protocol treatment
• Long-term administration of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. azathioprine, methotrexate)

Study & Design

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