NCT01578343

Vorinostat Plus FND in Relapsed or Refractory Mantle Cell Lymphoma

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Fludarabine, Mitoxantrone, Dexamethasone, Vorinostat	1. Induction treatment (Total 4 cycles) FND D1-3 Fludarabine 25mg/m2 + NS 100mL iv over 30 min D1 Mitoxantrone 10mg/m2 + NS 100mL iv over 30 min D1-5 Dexamethasone 20mg IV or PO every 4 weeks Vorinostat D1-10 Vorinostat 200mg once daily PO (When vorinostat is concurrently administered with FND regimen, vorinostat will be administered 3 hours before chemotherapy) 2. Consolidation treatment for responders Patients not eligible for transplantation * Vorinostat maintenance up to 6 cycles * 200mg twice daily for 14 consecutive days from D1 - 14 in a 21 day cycle * Delay of the start of the next cycle by up to 7 days will be acceptable. * If relapse or progression during maintenance, it will be stopped. Patients eligible for transplantation * High-dose chemotherapy followed by autologous stem cell transplantation

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-09-01
• Completion: 2016-02-01
• First posted: 2012-04-16
• Last updated: 2016-04-15

Locations

1 site across 1 country: South Korea