A total of 40 patients with a variety of hematological malignancies, including leukemias and lymphomas, have been enrolled in the study, with 40 patients evaluable for safety and 21 evaluable for efficacy. In three of seven lymphoma patients evaluable for efficacy, one patient (peripheral T-cell lymphoma) achieved a complete response, one patient (nodular sclerosis) is ongoing in cycle 3 with a PET scan interval response, and one patient (B-cell lymphoma) is ongoing with stable disease after five cycles of therapy.
Of 14 leukemia patients evaluable for efficacy, six patients achieved stable disease (three myelodysplastic syndromes and three chronic myelogenous leukemia) and one patient withdrew consent prior to efficacy evaluation.
Michael Craig, lead investigator of the study, said: “Administration of darinaparsin to patients diagnosed with advanced hematological malignancies has been well-tolerated, and tumor response, including a complete response in a highly refractory T-cell lymphoma patient, is very encouraging.”