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A multicenter phase II study of sepantronium bromide (YM155) plus rituximab in patients with relapsed aggressive B-cell Non-Hodgkin lymphoma
- Source :
- Leukemialymphoma. 57(8)
- Publication Year :
- 2016
-
Abstract
- This phase II study evaluated YM155, a novel small-molecule survivin suppressant, in combination with rituximab in patients with relapsed aggressive B-cell non-Hodgkin lymphoma (NHL) who failed or were not candidates for autologous stem cell transplant (ASCT). During 14-day cycles, 41 patients received YM155 (5mg/m(2)/d) by continuous intravenous (IV) infusion for 168 hours (day 1-7), and rituximab (375mg/m(2)) IV on days 1 and 8 during cycles 1-4 and repeated for 4 cycles every 10 cycles. Forty patients (97.6%) had prior rituximab and 15 patients (36.6%) prior ASCT. Most frequent grade 3-4 adverse events were neutropenia (19.5%) and thrombocytopenia (12.2%). In the per-protocol set (n = 34), objective response rate was 50% and median progression-free survival 17.9 months. Median overall survival was not reached at study termination (median follow-up, 23 months). YM155 in combination with rituximab was tolerable with encouraging antitumor activity and durable responses in relapsed aggressive B-cell NHL patients.
- Subjects :
- 0301 basic medicine
Male
Cancer Research
Survivin
Phases of clinical research
Gastroenterology
Inhibitor of Apoptosis Proteins
0302 clinical medicine
hemic and lymphatic diseases
Antineoplastic Combined Chemotherapy Protocols
Chemotherapy-Induced Febrile Neutropenia
Infusions, Intravenous
Aged, 80 and over
Imidazoles
Hematology
Middle Aged
Treatment Outcome
Oncology
030220 oncology & carcinogenesis
B-Cell Non-Hodgkin Lymphoma
Rituximab
Female
medicine.drug
Adult
medicine.medical_specialty
Lymphoma, B-Cell
Antineoplastic Agents
Neutropenia
Disease-Free Survival
Drug Administration Schedule
03 medical and health sciences
Internal medicine
medicine
Humans
In patient
Adverse effect
Aged
Neoplasm Staging
business.industry
medicine.disease
Thrombocytopenia
Lymphoma
Surgery
030104 developmental biology
Neoplasm Recurrence, Local
business
Follow-Up Studies
Naphthoquinones
Subjects
Details
- ISSN :
- 10292403
- Volume :
- 57
- Issue :
- 8
- Database :
- OpenAIRE
- Journal :
- Leukemialymphoma
- Accession number :
- edsair.doi.dedup.....7027b02549a021d04504c4bec1f479e9