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


Phase 3
18 Years
60 Years
Open (Enrolling)
Both
Hodgkin Lymphoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Andreas Engert, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cologne, German Hodgkin Study Group

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

HD17

NCT ID:

NCT01356680

Start Date:

December 2011

Completion Date:

December 2019

Related Keywords:

  • Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • intermediate stage
  • PET
  • Hodgkin Disease
  • Lymphoma

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