Hematological Oncology | 2019
TELLOMAK: T‐CELL LYMPHOMA ANTI‐KIR3DL2 THERAPY: AN OPEN LABEL, MULTI‐COHORT, MULTI‐CENTER, INTERNATIONAL PHASE II STUDY EVALUATING THE EFFICACY AND SAFETY OF IPH4102 ALONE OR IN COMBINATION WITH CHEMOTHERAPY IN PATIENTS WITH ADVANCED T‐CELL LYMPHOMA
Abstract
to assess overall response rate activity of the combination and ascertain additional safety information. Secondary endpoints include duration of response, PFS and OS and their relation to the COO, and BTK receptor occupancy in PBMCs and tumour measured by a drug analogue ELISA. The effect of acalabrutinib on antibody-directed cellular cytotoxicity mediated by rituximab will be measured in vitro during treatment. To date 22 (12 in dose escalation) of a planned 28 pts. have been recruited. In the phase Ib the maximal administered dose of A (100mg bd) with R-CHOP demonstrated no safety concerns beyond those seen with R-CHOP alone. In dose expansion, regardless of age, there has been no compromise in the delivery of full dose R-CHOP when given in combination with A. With anticipated full recruitment before 06/19, safety data, with CTDNA dynamics will be presented. The trial is coordinated by the CRUK Southampton Clinical Trials Unit. This is an investigator initiated study that has been granted free access to investigational medicinal product, trial management and translational study support through a grant from Acerta Pharma B.V. (IST-LY-801) and has endorsement from Cancer Research UK (CRUKDE/16/006). Trial registration: ISRCTN11965217 NCT03571308