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A study to improve the treatment in the first-line treatment of advanced stage Hodgkin lymphoma

Phase 1
Conditions
Treatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma
MedDRA version: 20.0Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disorders
Therapeutic area: Diseases [C] - Cancer [C04]
Registration Number
EUCTR2014-005130-55-AT
Lead Sponsor
niversity of Cologne
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
1585
Inclusion Criteria

Histologically proven classical Hodgkin lymphoma
First diagnosis, no previous treatment
Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV
Randomized main study: 18 to 60 years of age
Cohort of older patients: 61 to 75 yeras of age

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 1500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85

Exclusion Criteria

Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma
Previous malignancy (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
Prior chemotherapy or radiotherapy
Concurrent disease which precludes protocol treatment
Pregnancy, lactation
Non-Compliance

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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