Spots Global Cancer Trial Database for Phase I-II Study in CD30 Positive Diffuse Large B-cell Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse

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Trial Identification

Brief Title: Phase I-II Study in CD30 Positive Diffuse Large B-cell Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse

Official Title: Phase I-II Study Combining Brentuximab Vedotin With Second Line Salvage Chemotherapy (R-DHAP) in CD30 Positive Diffuse Large B-cell Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse Who Are Eligible for High Dose Treatment Followed by Autologous Stem Cell Transplantation

Study ID: NCT03356054

Conditions

DLBCL

Interventions

R-DHAP

Brentuximab Vedotin

Study Description

Brief Summary: 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.

Detailed Description: Patients with primary refractory or relapse diffuse large B cell lymphoma (DLBCL) after R-CHOP have a dismal prognosis. Only 25% long term survivors are observed after salvage with high-dose chemotherapy followed by autologous stem cell transplantation (ASCT). CD30 expression is observed in 30% of refractory/relapse DLBCL. Monotherapy with brentuximab vedotin is effective in relapse CD30 positive DLBCL. The addition of brentuximab vedotin to R-DHAP might improve the prognosis of these patients. Treatment will consist of 3 cycles of brentuximab-vedotin in combination with R-DHAP. During the phase I part the recommended dose level for this combination will be established. Cycles will be given every 3 weeks. Responsive patients will be treated with BEAM followed by ASCT. Total treatment duration is approximately 16 weeks. Subsequently patients will be followed until 5 years after registration.