NCT01449344

Efficacy and Safety of R-HAD Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory MCL

Efficacy and Safety of Rituximab, High-dose Ara-C and Dexamethasone (R-HAD) Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory Mantle Cell Lymphoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Prof. Dr. M. Dreyling (co-chairman) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of rituximab, high-dose ara-c and dexamethasone (r-had) alone or in combination with bortezomib in patients with relapsed or refractory mantle cell lymphoma.

Detailed description

This study is a prospective, randomized, multicenter, open-label phase III clinical trial to compare the efficacy and safety of Bortezomib in combination with Rituximab, high-dose Ara-C and dexamethasone (R-HAD) to R-HAD alone in patients with relapsed or refractory MCL after or not eligible for myeloablative treatment. The primary endpoint is time to treatment failure (TTF). Secondary endpoints are the complete response (CR) rate, the overall response (CR,PR) rate, the progression-free survival (PFS), the progression free survival of responders, the time to next lymphoma treatment, overall survival (OS), safety and tolerability of Rituximab, high-dose Ara-C and dexamethasone alone or in combination with Bortezomib. Study arms will be compared to each other to evaluate the impact of additional Bortezomib. Study arms will also be compared to historical controls.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab 375mg/m² IV , day 1
DRUG	High dose Ara-C	Ara-C 2000 mg/m² (patients \>65 years or s/p myeloablative treatment: 1000 mg/m²) IV, d 2 and 3
DRUG	Dexamethasone	Dexamethasone 40 mg PO, day 1-4
DRUG	Bortezomib	Bortezomib 1.5 mg/m² IV, day 1 and 4

Timeline

• Start date: 2009-05-09
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2011-10-10
• Last updated: 2017-03-07

Locations

54 sites across 2 countries: France, Germany