Mantle Cell Lymphoma Clinical Trial
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
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.
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
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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