A Phase II Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Treated With Gemcitabine Followed by Brentuximab Vedotin Maintenance
Patients treated with gemcitabine will receive Brentuximab Vedotin-induction for 4 cycles of induction.
- Patients who will obtain partial or complete response and who will be eligible for transplant will receive autologous or allogeneic stem cell transplantation.
- Patients who will obtain partial or complete response and who will not be eligible for transplant will receive maintenance therapy with Brentuximab Vedotin-maintenance every 3 weeks for 12 infusions.
- Age 18 years or older but < 80 years
- histologically proven, CD30 positive (at least 5% of cells according to local examination) peripheral T-cell lymphoma (PTCL) according to the 2016 WHO classification for whom gemcitabine treatment is expected
- evidence of relapsed disease after at least one line (and no more than three lines) of treatment or who were refractory to a first or subsequent line of treatment
- Ann Arbor stage I - IV
- ECOG score 0-2
- At least one measurable disease, i.e. one nodal or extra-nodal lesion of 1.5 cm or more
- Central nervous system and/or meningeal involvement by PTCL
- Signs or symptoms of Progressive Multifocal Leukoencephalopathy
- Preexistent peripheral neuropathy ≥ grade 2
- Previous treatment with brentuximab vedotin
- Previous treatment with gemcitabine
- UZ Brussel
- Institut Jules Bordet
- Cliniques Universitaires UCL Saint Luc
- CHU UCL Namur - site Mont-Godinne
- ULB Erasme Hospital