HD18 for advanced stages

Phase 1

• Conditions: Hodgkin´s Lymphomaadvanced stage; MedDRA version: 17.1Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-003187-22-AT
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-15
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2100

Inclusion Criteria

• Hodgkin lymphoma
• First diagnosis, no previous treatment, histologically proven,
• Age: 18-60 years
• Stage IIB with large mediastinal mass or extranodal lesions III, 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 2100
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 radiation
• 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

Name	Time	Method
Main Objective: Progression free survival (PFS);Secondary Objective: Overall survival<br>Acute and late toxicity of treatment<br>Quality of life<br>Secondary malignancy rate<br>CR rate<br>HL-specific death rate<br>Prognostic value of the PET-2 examination;Primary end point(s): Progression free survival (PFS);Timepoint(s) of evaluation of this end point: Inclusion of first patient 01 May 2008<br>End of recruitment 30 June 2014<br>Final analysis 30 June 2020<br>Subsequent follow-up observation of patients

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall survival<br>Acute and late toxicity of treatment<br>Quality of life<br>Secondary malignancy rate<br>CR rate<br>HL-specific death rate<br>Prognostic value of the PET-2 examination;Timepoint(s) of evaluation of this end point: Inclusion of first patient 01 May 2008<br>End of recruitment 30 June 2014<br>Final analysis 30 June 2020<br>Subsequent follow-up observation of patients