Spots Global Cancer Trial Database for Vorinostat Plus FND in Relapsed or Refractory Mantle Cell Lymphoma

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Trial Identification

Brief Title: Vorinostat Plus FND in Relapsed or Refractory Mantle Cell Lymphoma

Official Title: A Phase II Investigation of Vorinostat in Combination With Intravenous Fludarabine, Mitoxantrone, and Dexamethasone in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Study ID: NCT01578343

Conditions

Mantle Cell Lymphoma

Interventions

Fludarabine, Mitoxantrone, Dexamethasone, Vorinostat

Study Description

Brief Summary: 1. Rationale In mantle cell lymphoma, the conventional chemotherapy achieves only temporary responses with a median duration of remissions only from 1 to 2 years. Therefore, mantle cell lymphoma is known as one of the B-cell lymphomas with poor prognosis. Although the treatment outcome of mantle cell lymphoma has been improved since intensive chemotherapy regimens such as HyperCVAD was used, a substantial number of patients are still frequently relapsed after chemotherapy. After relapse, most of them became refractory to various kinds of salvage treatment. That is why the results of most salvage chemotherapy regimens were disappointing. In addition, mantle cell lymphoma generally occurs in elderly people. Thus, intensive salvage chemotherapy may not be feasible for elderly patients. Therefore, an effective, novel combination treatment is urgently needed in relapsed or refractory mantle cell lymphoma patients. 2. Hypothesis * Vorinostat will produce synergism with a combination treatment regimen (Fludarabine, mitoxantrone, dexamethasone, FND) without overlapping toxicity * Vorinostat maintenance treatment will reduce the relapse rate in patients ineligible for autologous stem cell transplantation. 3. Purpose A phase II investigation to determin the effectiveness of vorinostat in combination with intravenous fludarabine, mitoxantrone, and dexamethasone in patients with relapsed or refractory mantle cell lymphomain patients with relapsed or refractory mantle cell lymphoma.

Detailed Description: 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