A Phase 1/2 interventional study of Bendamustine hydrochloride and Gemcitabine 500 mg in Diffuse Large B Cell Lymphoma, sponsored by St. Petersburg State Pavlov Medical University. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-06-07.
Sponsored by St. Petersburg State Pavlov Medical University · Phase 1/2, Interventional, and Treatment
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.
Exclusion Criteria:
Days 1,2 Bendamustine Hydrochloride 70 mg/m2/day iv; Days 1,8,15 Gemcitabine 500 mg/m2/day iv; Days 1,15 Nivolumab 1mg/kg/day iv; Day 0 Rituximab 375mg/kg/day iv. Duration of cycle 28 days
Drug: Bendamustine hydrochloride · Drug: Gemcitabine 500 mg · Drug: Nivolumab · Drug: Rituximab
Days 1,2 Bendamustine Hydrochloride 70 mg/m2/day iv; Days 1,8,15 Gemcitabine 700 mg/m2/day iv; Days 1,15 Nivolumab 1mg/kg/day iv; Day 0 Rituximab 375mg/kg/day iv. Duration of cycle 28 days
Drug: Bendamustine hydrochloride · Drug: Gemcitabine 700 mg · Drug: Nivolumab · Drug: Rituximab
Days 1,2 Bendamustine Hydrochloride 70 mg/m2/day iv; Days 1,8,15 Gemcitabine 1000 mg/m2/day iv; Days 1,15 Nivolumab 1mg/kg/day iv; Day 0 Rituximab 375mg/kg/day iv. Duration of cycle 28 days
Drug: Bendamustine hydrochloride · Drug: Gemcitabine 1000 mg · Drug: Nivolumab · Drug: Rituximab
70 mg/m2 by intravenous (IV) infusion for up to 2 cycles
Also known as: Ribomustin
500 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles
Also known as: Gemzar
700 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles
Also known as: Gemzar
1000 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles
Also known as: Gemzar
1 mg/kg by intravenous (IV) infusion on day 1,15 for up to 2 cycles
Also known as: Opdivo
375 mg/m2 by intravenous (IV) infusion on day 0 for up to 2 cycles
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
Plan to share: Undecided
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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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St. Petersburg State Pavlov Medical University