Vorinostat Plus FND in Relapsed or Refractory Mantle Cell Lymphoma
Status:
Terminated
Trial end date:
2016-02-01
Target enrollment:
Participant gender:
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.