Despite the current advances in clinical oncology, the prognosis of patients with resistant diffuse large B cell lymphoma or relapse after high dose chemotherapy is dismal. Therefore there is a need for the introduction of novel treatment regimens. This phase I/II trial evaluates the safety and efficacy of combination bendamustine, gemcitabine, nivolumab and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. The safety of combination treatment will be evaluated with the determination of recommended dose schedule prior to expansion of enrollment to evaluate the antitumor activity of bendamustine, gemcitabine, rituximab, and nivolumab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
70 mg/m2 by intravenous (IV) infusion for up to 2 cycles
500 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles
700 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles
1000 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles
1 mg/kg by intravenous (IV) infusion on day 1,15 for up to 2 cycles
375 mg/m2 by intravenous (IV) infusion on day 0 for up to 2 cycles
First Pavlov State Medical University of St. Petersburg
Saint Petersburg, Russia
The recommended phase 2 dose (RP2D)
The recommended phase 2 dose (RP2D) of Bendamustine Hydrochloride and Gemcitabine in combination with Nivolumab and Rituximab in patients with Diffuse Large B-cell Lymphoma
Time frame: 6 months
Overall Response Rate (ORR)
Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC criteria and duration of response.
Time frame: 12 months
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).
Time frame: 12 months
Duration of Response (DOR)
Time frame: 12 months
Progression-Free Survival (PFS)
Time frame: 12 months
Overall Survival (OS)
Time frame: 12 months
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