CyBeR Association in Relapsed/Refractory DLBCL

Sponsor
University Hospital, Caen
Study ID
NCT02758925
Phase
PHASE2
Status
Unknown

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    375mg/m2 IV day 1
  • Bendamustine — DRUG
    90mg/m2 IV day 1-2
  • Cytarabine — DRUG
    1000mg/m2 or 750mg/m2 at day 2 if patients aged more than 70 years or toxicity grade 3/4

Study Details

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.

Key Dates

Start date
Jun 30, 2016
Status verified
May 2016
Primary completion
Nov 30, 2018
Completion
Dec 31, 2018

Study Design

Enrollment
78 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DLBCL patients
    they will receive a combination of: Rituximab 375mg/m2 IV at Day 1 Bendamustine 90mg/m2 IV at Day 1 and 2 Cytarabine 1000mg/m2 IV at day 2 every 21 days for 6 cycles

Primary Outcome Measure

treatment response [ Time Frame: up to 20 weeks (at the end of the treatment) ]

Central Contacts

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