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NCT01356680 Clinical Trial

HD17 for Intermediate Stage Hodgkin Lymphoma

Hodgkin Lymphoma Clinical Trial

Official title:
HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01356680
Other study ID # HD17
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 13, 2012
Est. completion date March 23, 2020

Study information
Verified date April 2020
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (PFS).

Recruitment information / eligibility
Status Completed
Enrollment 1100
Est. completion date March 23, 2020
Est. primary completion date March 21, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Hodgkin Lymphoma

- CS I, II with risk factor (stage IIB with risk factor 1 or 2 are not included)

- large mediastinal mass (>1/3 of maximum transverse thorax diameter)

- extranodal involvement

- elevated ESR

- 3 or more involved nodal areas

- written informed consent

Exclusion Criteria:

- Leucocytes <3000/µl

- Platelets < 100000/µl

- Hodgkin Lymphoma as composite lymphoma

- Activity Index (WHO) >2

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)

• ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)

Radiation:
• 30Gy IF-RT (Involved-Field Radiotherapy)

• 30Gy IN-RT (Involved-Node Radiotherapy)

Locations
Country Name City State
Germany 1st Dept. of Medicine, Cologne University Hospital Cologne

Sponsors (1)
Lead Sponsor Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression Free Survival 3 years
Secondary Overall Survival 3 years
Secondary CR rate Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment 6 months
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