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HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET


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

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Trial Information

HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET


Inclusion Criteria:



- Hodgkin Lymphoma

- CS I, II without risk factors

- 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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Andreas Engert, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cologne

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

HD16

NCT ID:

NCT00736320

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • early stage
  • PET
  • Hodgkin Disease
  • Lymphoma

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