Phase 1 trial of carfilzomib in relapsed/refractory peripheral T-cell lymphoma

Mridula Krishnan, R. Gregory Bociek, Michelle Fanale, Swaminathan P. Iyer, Mary Jo Lechowicz, Philip J. Bierman, James O. Armitage, Matthew Lunning, Avyakta Kallam, Julie M. Vose

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Peripheral T-cell lymphomas (PTCL) are a unique subset of lymphomas with a poor prognosis due to limited treatment options. We performed a phase 1 study of carfilzomib in patients with relapsed/refractory PTCL to determine the safety profile and the maximum tolerated dose (MTD) of this agent. The study was a classical 3 + 3 phase 1 design with intra-patient dose escalation allowed beginning on day 8 of cycle 1 and subsequently. Dose-limiting toxicity (DLT) was defined as the occurrence of any grade 3/4 adverse event. Carfilzomib was given on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. Fifteen patients were enrolled from 3 centers. The median age of patients was 62. The median number of prior therapies for subjects on this trial was five. The MTD of carfilzomib was 36 mg/m2. Dose-limiting toxicities included anemia and sepsis. Serious adverse events were seen in 45% of patients. Single-agent carfilzomib leads to a complete response in one patient and a partial response in one patient. Overall, the drug was reasonably tolerated for a heavily pretreated population, but the limited response rate and short duration of response demonstrate a lack of promise for carfilzomib as a single agent in this patient population.

Original languageEnglish (US)
Pages (from-to)335-340
Number of pages6
JournalAnnals of Hematology
Volume101
Issue number2
DOIs
StatePublished - Feb 2022
Externally publishedYes

Keywords

  • Carfilzomib
  • PTCL
  • Phase 1 trial

ASJC Scopus subject areas

  • Hematology

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