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Completed

NCT Number: NCT01356680

HD17 for Intermediate Stage Hodgkin Lymphoma

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).

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1st Dept. of Medicine, Cologne University Hospital

Cologne, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)

Drug

ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)

Drug

30Gy IF-RT (Involved-Field Radiotherapy)

Radiation

30Gy IN-RT (Involved-Node Radiotherapy)

Radiation

Primary outcomes

  1. Progression Free Survival

    Time frame: 3 years

Secondary outcomes

  1. Overall Survival

    Time frame: 3 years

  2. CR rate

    Time frame: 6 months

    Rate of patients achieving a complete remission (CR/CRu) at final restaging after completion of study treatment

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
May 19, 2011
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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