A Phase II Investigation of Vorinostat in Combination With Intravenous Fludarabine, Mitoxantrone, and Dexamethasone in Patients With Relapsed or Refractory Mantle Cell Lymphoma
1. Objectives 1.1 Primary objective • To determine the efficacy of vorinostat plus FND as
an induction treatment
- Response rate of vorinostat/FND 1.2 Secondary objective
- Survival outcome
- Overall survival and progression-free survival
- To determine the efficacy of vorinostat maintenance treatment
- Relapse rate • Toxicity of vorinostat/FND
- Hematologic and non-hematologic toxicity
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the efficacy of vorinostat plus FND as an induction treatment confirmed by CT or MRI (PET/CT as indicated)
B) Response criteria 1) Complete response (CR): Disappearance of all detectable clinical and radiographic evidence of disease 2) Partial response (PR): ≥50% decrease in sum of product diameter (SPD) of 6 nodes/nodal masses 3) Stable disease (SD): Disease status is less than PR, but is not PD 4) Progressive disease (PD): Appearance of any new lesions
A) After 8weeks and 16 weeks of the treatment
Yes
Won Seog Kim, MD, PhD
Principal Investigator
Samsung Meical Center
South Korea: Korea Food and Drug Administration (KFDA)
SMC2011-11-102-001
NCT01578343
January 2013
September 2016
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