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Phase I-II Study in CD30 Positive Diffuse Large B-cell Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse — HOVON 136 NHL  

DLBCL Clinical Trial

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

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

Clinical Trial Details
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
View Details
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