HOVON 136 (R/R)
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 treatment
Arm | Intervention/treatment |
---|---|
Experimental: Brentuximab vedotin-R-DHAPBrentuximab vedotin added to R-DHAP | Combination Product: R-DHAP3 cycles q 3 weeks
Drug: Brentuximab Vedotin3 cycles q 3 weeks added to R-DHAP |
Inclusion criteria
- CD30 positive DLBCL, i.e. more than 1% of DLBCL cells CD30 positive(central pathology review results not required to enter patient into the study), according to the WHO classification 2008:
- 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
- Age ≥ 18 years (upper age limit for ASCT at the discretion of the participating center)
- Measurable disease: on CT scan at least 1 lesion/node with a long axis of > 1.5 cm and at least one positive lesion on 18F-FDG PET scan
- WHO performance status 0-2, status 3 only if disease related
Exclusion criteria
- Administration of cytotoxic agent(s) for cytoreduction within three weeks prior to initiation of the treatment or to be expected within 8 weeks after administration of the treatment
- Karnofsky performance score < 60%
- Patient with active aGVHD grade 3 or more
- Patient with severe chronic GVHD
Participating sites
- ZNA