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 Journal Article
| Authors: | Ryu Tiger, Y. K.; Jain, S.; Barta, S. K.; Tolu, S.; Estrella, B.; Sawas, A.; Lue, J. K.; Francescone, M. M.; Pro, B.; Amengual, J. E. |
| Article Title: | 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 |
| Abstract: | 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/m2 and romidepsin 12 mg/m2 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 (NCT 01947140). © 2024 Informa UK Limited, trading as Taylor & Francis Group. |
| Keywords: | adult; clinical article; controlled study; treatment outcome; treatment response; aged; aged, 80 and over; middle aged; antibiotic agent; unclassified drug; histone deacetylase inhibitor; prednisone; clinical trial; constipation; fatigue; doxorubicin; interferon; diarrhea; drug efficacy; treatment duration; gemcitabine; methotrexate; outcome assessment; antineoplastic agent; anorexia; carboplatin; multiple cycle treatment; pain; phase 2 clinical trial; anemia; etoposide; gastrointestinal symptom; nausea; stomatitis; vomiting; antineoplastic combined chemotherapy protocols; clinical assessment; cyclophosphamide; dexamethasone; pathology; ifosfamide; abdominal pain; dizziness; fever; dysphagia; hypokalemia; hyponatremia; vincristine sulfate; peripheral t cell lymphoma; t cell lymphoma; lymphoma, t-cell; epigenetics; heart failure; multicenter study; folinic acid; clinical evaluation; vorinostat; histone deacetylase inhibitors; asparaginase; ondansetron; sepsis; antiemetic agent; folic acid; headache; somnolence; drug therapy; disease control; oxaliplatin; folic acid antagonist; folic acid antagonists; t-cell lymphoma; atrial fibrillation; romidepsin; disease exacerbation; pralatrexate; aminopterin; depsipeptides; small intestine obstruction; histone deacetylase; cerebrovascular accident; upper respiratory tract infection; analgesic agent; appendicitis; antihistaminic agent; cyanocobalamin; nose obstruction; sinus tachycardia; depsipeptide; antidiarrheal agent; sore throat; antifolate; 10-propargyl-10-deazaaminopterin; otitis media; phase 1 clinical trial (topic); overall response rate; colony stimulating factor; antipyretic agent; staphylococcal bacteremia; lymphoma and hodgkin disease; chemotherapeutic approaches; clinical results; very elderly; humans; human; male; female; article; nalelbine; lymph node infection |
| Journal Title: | Leukemia and Lymphoma |
| Volume: | 65 |
| Issue: | 6 |
| ISSN: | 1042-8194 |
| Publisher: | Taylor & Francis Group |
| Date Published: | 2024-01-01 |
| Start Page: | 736 |
| End Page: | 745 |
| Language: | English |
| DOI: | 10.1080/10428194.2024.2329996 |
| PUBMED: | 38517235 |
| PROVIDER: | scopus |
| PMCID: | PMC11162072 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
