Diffuse Large B Cell Lymphoma Clinical Trial
Official title:
Phase 2 Study of Cytarabine in Association With Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B Cell Lymphoma
Forty percent of patients with diffuse large B cell lymphoma (DLBCL) have primary refractory
or relapsed disease (R/R). For these fit patients, standard treatment in second line therapy
is high dose therapy with autologous stem cell transplantation (ASCT). In 48% of DLBCL no
ASCT is possible due to progressive disease. For these patients or ineligible to
transplantation patients, salvage therapy is often rituximab-gemcitabine-oxaliplatine
regimen with an overall response rate (ORR) about 50%.
Bendamustine in combination with rituximab, used as a single agent in the setting of R/R
DLBCL patients, have shown an ORR of 62.7% and 45.8% with a good safety profile.
Bendamustine and cytarabine (BAC) showed high synergy in inducing cell death in mantle cell
lymphoma and DLBCL cell lines. In a recent phase II study, the combination of cytarabine
with Rituximab and Bendamustine (R-BAC) in patients with mantle cell lymphoma who were
previously untreated, refractory or relapsed was evaluated.
The efficacy and safety of the R-BAC association will be evaluated in this phase II trial
enrolling 78 patients with relapsed or refractory DLBCL.
Participants will received 6 cycles every 21 days with a follow-up period of 24 months.
CT-Scan after 3 cycles and at the end of the treatment will be used to assess treatment
response, established with Cheson criteria in 1999.
Principal objective is to obtain an overall response rate of 60% (corresponding to an
increased of 15% of the rituximab-gemcitabine-oxaliplatine regimen's overall response rate).
Secondaries objectives are to value toxicity, progression free survival and overall
survival.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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