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Prognosis of patients with Hodgkin´s lymphoma (HL) has been improved significantly over the last decade. Therefore, the impact of treatment associated long-term toxicities and late effects such as second cancers increased. The purpose of this prospective multicenter trial is to show the feasibility of the treatment with ABVD alone in patients with limited stage (HL1) and intermediate stage (HL2) disease and of an intensified etoposide-free chemotherapy regimen for patients with advanced disease (HL3) including 18F-FDG-PET evaluation.
Full description
The aim in limited and intermediate stages is to reduce the toxicity by omitting the subsequent radiotherapy in patients with complete remission after ABVD chemotherapy. Patients with limited disease receive four cycles, patients with intermediate disease (according to the criteria of the German Hodgkin Study group, GHSG) receice six cycles of ABVD. In case of residual mass (> 1.5 cm), additional involved field irradiation is planned. The aim in advanced disease using BACOPP-D regimen which includes cyclophosphamide, adriamycin, dacarbazine, procarbazine, prednisolone, bleomycin and vincristine, is to reduce the hematological toxicity and the secondary leukemias by omitting etoposide (in comparison to the BEACOPP escalated regimen). All patients receive eight cycles of the BACOPP-D regimen. In case of residual mass (> 1.5 cm), additional involved field irradiation is planned. Additionally, we want to evaluate the CT- and PET-based remission status after chemotherapy and at final staging.
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Inclusion and exclusion criteria
Inclusion Criteria (HL1):
Histologically confirmed Hodgkin´s Lymphoma (WHO Classification 1999)
Patients in stage: Clinical stage (CS) I without risk factors / CS II without risk factors
Age between 16 and 75
Written informed consent
Inclusion criteria (HL2):
Histologically confirmed Hodgkin´s Lymphoma (WHO Classification 1999)
Patients in stage
Age between 16 and 75
Written informed consent
Inclusion criteria (HL3):
Histologically confirmed Hodgkin´s Lymphoma (WHO Classification 1999)
Patients in stage
Age between 16 and 65
Written informed consent
Exclusion Criteria (HL1, HL2 and HL3):
Primary purpose
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Interventional model
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Central trial contact
Ralph Naumann, MD
Data sourced from clinicaltrials.gov
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