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HD17 for Intermediate Stage Hodgkin Lymphoma

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01356680
Enrollment
1100
Registered
2011-05-19
Start date
2012-01-13
Completion date
2020-03-23
Last updated
2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin Lymphoma

Keywords

Hodgkin Lymphoma, intermediate stage, PET

Brief 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).

Interventions

DRUGBEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)
DRUGABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)
RADIATION30Gy IF-RT (Involved-Field Radiotherapy)
RADIATION30Gy IN-RT (Involved-Node Radiotherapy)

Sponsors

University of Cologne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Progression Free Survival3 years

Secondary

MeasureTime frameDescription
Overall Survival3 years
CR rate6 monthsRate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026