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
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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Change from Baseline of diseased nodes and nodal masses.
Average time frame is three weeks after the first two cycles of trial therapy and 4 to 6 weeks after the end of trial therapy. Response is always evaluated in comparison to the status before start of trial therapy. The assessment will be done with CT of all known lymphoma manifestations. In case of isolated bone marrow involvement a bone marrow aspiration/ biopsy is mandatory. A minimum of 50 % decrease in SPD (sum of the products of the greatest diameters) of the six largest nodes or nodal masses are necessary, in order to be able to evaluate it as partly remission.
approx. 66 and 126 days after start of therapy
Martin Dreyling, MD
Klinikum der Universität München, Grosshadern
Germany: Federal Institute for Drugs and Medical Devices