Copanlisib and Gemcitabine in Relapsed/Refractory PTCL
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
COPGEM (Copanlisib and Gemcitabine)chemotherapy regimen is proposed as the salvage treatment
for relapsed or refractory peripheral T-cell or NK/T-cell lymphomas in this study protocol,
which would be expected to be feasible and effective in this group of patients.
Copanlisib (BAY 80-6946), a highly selective and potent class-1 PI3K inhibitor with
sub-nanomolar IC50s against PI3Kα and PI3Kδ, has demonstrated activity in
relapsed/refractory, aggressive NHLs, suggesting an ORR of 50% for T-cell lymphomas.
Gemcitabine has demonstrated clinical antitumor activity against PTCLs including NK/T-cell
lymphomas both as single-agent (ORR 30-50%) and in combination therapy, with limited
extramedullary toxicities.
Considering the evidence of activity for both agents against PTCLs, the investigators propose
that targeted therapy with copanlisib in combination with gemcitabine will exhibit early
elimination of rapidly growing tumor cells and be a rational therapeutic modality for use in
relapsed or refractory PTCLs, if the overlapping toxicities can be managed.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Chonnam National University Hospital
Collaborators:
Bayer Consortium for Improving Survival of Lymphoma