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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03356054
Study type Interventional
Source Stichting Hemato-Oncologie voor Volwassenen Nederland
Contact P.J. Lugtenburg, Dr.
Phone +31 (0)10 7031672
Email p.lugtenburg@erasmusmc.nl
Status Recruiting
Phase Phase 1/Phase 2
Start date March 5, 2018
Completion date February 2027

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