Phase II study of the novel antifolate agent pralatrexate in combination with the histone deacetylase inhibitor romidepsin for the treatment of patients with mature T-cell lymphoma.

Autor: Ryu Tiger YK; Division of Hematology and Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA., Jain S; Division of Hematology and Oncology, Department of Medicine, Massachusetts General Hospital Cancer Center, Boston, MA, USA.; Harvard Medical School, Boston, MA, USA.; Broad Institute, Cambridge, MA, USA., Barta SK; Division of Hematology and Oncology, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.; Department of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA., Tolu S; Division of Hematology and Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA., Estrella B; Division of Hematology and Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA., Sawas A; Division of Hematology and Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA., Lue JK; Division of Hematology and Oncology, Memorial Sloan Kettering, New York, NY, USA., Francescone MM; Department of Radiology, Columbia University Irving Medical Center, New York, NY, USA., Pro B; Division of Hematology and Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA., Amengual JE; Division of Hematology and Oncology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA.
Jazyk: angličtina
Zdroj: Leukemia & lymphoma [Leuk Lymphoma] 2024 Jun; Vol. 65 (6), pp. 736-745. Date of Electronic Publication: 2024 Mar 22.
DOI: 10.1080/10428194.2024.2329996
Abstrakt: Previously, we conducted a Phase I study of the combination of pralatrexate and romidepsin in patients with relapsed/refractory (R/R) lymphomas and subsequently conducted a multicenter Phase II study in patients with untreated or R/R mature T cell lymphomas (MTCL). Patients received pralatrexate 25 mg/m 2 and romidepsin 12 mg/m 2 every 2 weeks. Fourteen patients were evaluable for efficacy. Overall response rate was 35.7% with CR in 14.3% and disease control in 50%. The mDOR was 8.2 months, mPFS was 3.6 months, and mOS was 20.2 months. Gastrointestinal side effects were most common in up to 33%; there was only one hematologic toxicity of grade 3 anemia. Combining results of MTCL patients from the Phase I and II studies ( N  = 28), the ORR was 53.5% with CR in 21.4%, disease control in67.8%, and DOR of 7.2 months. The combination was safe however does not out-perform other combination strategies. Trial Registration: www.clinicaltrials.gov (NCT01947140).
Databáze: MEDLINE