Status and phase
Conditions
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About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Person under guardianship or curatorship , or unable to understand the purpose of the study
Central nervous system or meningeal involvement
WHO performance status more than 2
Contraindication to any drug contained in the chemotherapy regimen
HIV disease, active hepatitis B or C
Any serious active disease or co-morbid medical condition
Any of the following laboratory abnormalities.
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or lactating females.
Prior history of malignancies, other than lymphoma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
renal impairment with an estimated (modified dietin renal disease; MDRD) creatinine clearance < 40 ml/min,
chronic liver disease or day-1 (AST/ALT )≥2.5 upper limit of normal (ULN), total bilirubin≥1.5 ULN,
Primary purpose
Allocation
Interventional model
Masking
78 participants in 1 patient group
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Central trial contact
Emilie Reboursiere, MD
Data sourced from clinicaltrials.gov
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