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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
Rituximab 375mg/m² IV , day 1
Ara-C 2000 mg/m² (patients \>65 years or s/p myeloablative treatment: 1000 mg/m²) IV, d 2 and 3
Dexamethasone 40 mg PO, day 1-4
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.
Time frame: approx. 66 and 126 days after start of therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bortezomib 1.5 mg/m² IV, day 1 and 4
CH Victor Dupouy, Service hématologie
Argenteuil, France
Centre Hospitalier de la côte Basque, Service hématologie
Bayonne, France
CH de Blois, Service hématologie
Blois, France
Institut Bergonie, Service Hématologie
Bordeaux, France
CH Sud Francilien de Corbeil, Service hématologie
Corbeil-Essonnes, France
Hôpital Henri Mondor, Service hématologie
Créteil, France
Hôpital Albert Michallon, Service hématologie
Grenoble, France
CH Mulhouse, Service hématologie
Le Mans, France
Clinique Victor Hugo, Service hématologie
Le Mans, France
CH du Mans, Service hématologie
Le Mans, France
...and 44 more locations