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HD18

  • Advanced Stage

Materials

Purpose / Objectives

Primary objective

The purpose of this study is to individualize treatment according to early response to chemotherapy. Only patients with poor response receive intensified treatment while the toxicity of therapy for those with good response is to be reduced without compromising the treatment results.

Patient attributes

Stage

  • IIB (with large mediastinal mass and/or extranodal involvement as risk factors), III A/B and IV A/B

Age

  • 18-60

Inclusion criteria

  • Histologically confirmed diagnosis of Hodgkin lymphoma: 
    • CS (PS) IIB with one or both of the following risk factors: 
      • Large mediastinal mass (> one third of the maximum transverse thorax diameter),
      • Extranodal involvement (see 14.3.4 for definitions)
    • CS (PS) III, IV
  • Patient has not received any previous treatment for HL
  • Age: 18-60
  • Patient has given their written informed consent to participate in the trial
  • Patient has given their written informed consent to the storage of his data and use of his tissue samples; normal organ function (except HL-related)
  • Negative HIV serology
  • In women: negative pregnancy test
  • Life expectancy > three months

Exclusion criteria

  • Participation in another interventional trial that might interact with this trial
  • Hodgkin lymphoma as composite lymphoma
  • Other malignant disease
  • Prior chemotherapy or radiotherapy
  • Prior or concurrent disease that prevents treatment according to protocol
  • Pregnancy, lactation
  • Non-compliance

Study Design

  • Phase III
  • Multicenter
  • Randomized

Intervention

For patients that show PET-positive lesions after two cycles of chemotherapy it is to be demonstrated that eight cycles of escalated BEACOPP + rituximab are superior to eight cycles of chemotherapy alone with regard to the primary endpoint of progression-free survival (PFS). For patients with PET-negative lesions after two cycles of chemotherapy it is to be demonstrated that the experimental arm (four cycles of escalated BEACOPP) is not inferior to standard treatment (eight cycles of escalated BEACOPP) with regard to the primary endpoint of PFS.

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