Patients with CD30 positive DLBCL, primary refractory or in first relapse after R-CHOP or R-CHOP-like therapy will receive brentuximab vedotin in combination with R-DHAP, followed in responsive patients by high dose chemotherapy and ASCT.
CD30 positive DLBCL, including EBV positive DLBCL
CD30 positive primary mediastinal B-cell lymphoma
Primary refractory to or in first relapse after first line therapy with R-CHOP or R-CHOP-like therapy
Relapse is defined as biopsy confirmed CD30 positive DLBCL after a complete response. The relapse must be histologically confirmed. In case a surgical biopsy is not possible, at least confirmation by FNA biopsy is required
Peripheral sensory or motor neuropathy grade ≥ 2
Known cerebral or meningeal disease (NHL or any other etiology), including signs and symptoms of progressive multifocal leukoencephalopathy (PML)
Symptomatic neurological disease compromising normal activities of daily living or requiring medications
Transformed lymphoma
Single group
R-DHAP
Combination product3 cycles q 3 weeks
Brentuximab Vedotin
Drug3 cycles q 3 weeks added to R-DHAP
The rate of patients with serious toxicity during cycle 1-2 of the combination brentuximab vedotin-R-DHAP
Phase I
Metabolic CR rate (PET-diagnostic CT) after the third cycle of brentuximab vedotin-R-DHAP salvage therapy
Phase II
Rate of CTCAE grade 3/4 non-hematological toxicity, including neurotoxicity after each cycle of brentuximab vedotin-R-DHAP
Phase II
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