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A study to improve the treatment in the first-line treatmend 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-NL
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
1500
Inclusion Criteria

Histologically proven classical Hodgkin lymphoma
First diagnosis, no previous treatment, 18 to 60 years of age
Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV

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) no
F.1.3.1 Number of subjects for this age range

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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