A Phase 1/2 interventional study of Nivolumab and Bendamustine Hydrochloride in Hodgkin's 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 2020-05-28.
Sponsored by St. Petersburg State Pavlov Medical University · Phase 1/2, Interventional, and Treatment
A clinical study of safety and efficacy of treatment with Nivolumab and Bendamustine (NB) in patients with relapsed/refractory Hodgkin's lymphoma.
1,383 studies on the registry are indexed under Hodgkin Disease; 163 are open to participants now.
This study's enrollment of 30 is below the median of 40 across 1,095 interventional studies indexed under Hodgkin Disease.
Browse Hodgkin Disease studies →St. Petersburg State Pavlov Medical University is the lead sponsor of 52 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nivolumab 3 mg/kg IV infusion on day 1,14 + Bendamustine hydrochloride 90 mg/kg IV infusion on day 1,2 up to 3 cycles. Duration of cycle 28 days
Drug: Nivolumab · Drug: Bendamustine Hydrochloride
3 mg/kg IV infusion on day 1,14 up to 3 cycles
Also known as: Opdivo
90 mg/kg IV infusion on day 1 up to 3 cycles
Also known as: Ribomustin
Overall Response Rate (ORR) of Nivolumab in combination with Bendamustine Hydrochloride in patients with Hodgkin's lymphoma
Overall response rate (ORR), defined as 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: up to 3 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: up to 12 months
Duration of Response (DOR)
Duration of response will be measured from the time of initial response to nivolumab till documented disease progression, death or last evaluation of tumor status.
Time frame: up to 12 months
Time to Progression (TTP)
Time frame: up to 12 months
Progression-Free Survival (PFS)
Time frame: up to 12 months
Overall Survival (OS)
Time frame: up to 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from May 2017 to primary completion in Mar 2019, 22 months.
Of 48 non-industry phase 1/2 interventional studies under Hodgkin Disease, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 59 and three quarters within 103. This study's 22 months is below that.
Counting every sponsor, half of 63 studies reached it within 69 months; a quarter within 53 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Nivolumab · Bendamustine
St. Petersburg State Pavlov Medical University