Hodgkin's LymphomaPhase 1/2NB001NCT03343652
A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma
A Phase 1/2 study testing Nivolumab and Bendamustine Hydrochloride in people with Hodgkin's Lymphoma, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
Trial summary
A clinical study of safety and efficacy of treatment with Nivolumab and Bendamustine (NB) in patients with relapsed/refractory Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hodgkin's Lymphoma
- What is being tested?
- Nivolumab and Bendamustine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 27 May 2017to 27 Mar 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: Histologically confirmed Hodgkin's lymphoma
- Relapsed or refractory to at least two prior treatment lines
- Relapsed after nivolumab treatment or refractory to nivolumab treatment
- Age 18-70 years old
- Signed informed consent
- No severe concurrent illness
Who cannot join
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Requirement for vasopressor support at the time of enrollment
- Karnofsky index <30%
- Pregnancy
- Somatic or psychiatric disorder making the patient unable to sign informed consent
- Active or prior documented autoimmune disease requiring systemic treatment.
Trial locations and contacts
1 site in 1 country.
Russia1 site
First Pavlov State Medical University of St. Petersburg
Saint Petersburg, 197089
About this study
Official title: A Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Nivolumab and Bendamustine Combination (NB) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
A clinical study of safety and efficacy of treatment with Nivolumab and Bendamustine (NB) in patients with relapsed/refractory Hodgkin's lymphoma.
- Conditions
- Hodgkin's Lymphoma
- Being tested
- Nivolumab, Bendamustine Hydrochloride
- Keywords
- Hodgkin's Lymphoma, Nivolumab, Bendamustine Hydrochloride
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
3 mg/kg IV infusion on day 1,14 up to 3 cycles
Bendamustine HydrochlorideDrug
Also called Ribomustin
90 mg/kg IV infusion on day 1 up to 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| NB | Experimental | 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 Receives: Drug: Nivolumab; Drug: Bendamustine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 months
Secondary outcomes (5)
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).
Measured: 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.
Measured: up to 12 months
Time to Progression (TTP)
Measured: up to 12 months
Progression-Free Survival (PFS)
Measured: up to 12 months
Overall Survival (OS)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start27 May 2017
- Primary completion27 Mar 2019
- Study completion27 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan S Moiseev, St. Petersburg State Pavlov Medical University
- Investigators
- Boris V Afanasyev, PhD, Study director, First Pavlov State Medical University of St. Petersburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343652
- Sponsor's protocol ID
- 10/17-n
- Acronym
- NB001
- Status last verified
- May 2020
- First submitted
- 12 Nov 2017
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Nivolumab and Bendamustine Combination (NB) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT03343652
- Acronym / sponsor ID
- NB001 / 10/17-n
- Conditions
- Hodgkin's Lymphoma
- Keywords
- Hodgkin's Lymphoma, Nivolumab, Bendamustine Hydrochloride
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 27 May 2017 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A clinical study of safety and efficacy of treatment with Nivolumab and Bendamustine (NB) in patients with relapsed/refractory Hodgkin's lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NB | Experimental | Drug: Nivolumab, Drug: Bendamustine HydrochlorideNivolumab 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis: Histologically confirmed Hodgkin's lymphoma
- Relapsed or refractory to at least two prior treatment lines
- Relapsed after nivolumab treatment or refractory to nivolumab treatment
- Age 18-70 years old
- Signed informed consent
Key exclusion criteria (6 listed)
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Requirement for vasopressor support at the time of enrollment
- Karnofsky index <30%
- Pregnancy
- Somatic or psychiatric disorder making the patient unable to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: Opdivo3 mg/kg IV infusion on day 1,14 up to 3 cycles | Drug | NB |
| Bendamustine HydrochlorideAlso: Ribomustin90 mg/kg IV infusion on day 1 up to 3 cycles | Drug | NB |
Primary outcome
Overall Response Rate (ORR) of Nivolumab in combination with Bendamustine Hydrochloride in patients with Hodgkin's lymphoma
Time frame: up to 3 months
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.
5 secondary outcomes
Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
Time frame: up to 12 months
Duration of Response (DOR)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris V Afanasyev, PhD study director
First Pavlov State Medical University of St. Petersburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nivolumab and Bendamustine Hydrochloride in people with Hodgkin's Lymphoma, run by St. Petersburg State Pavlov Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) of Nivolumab in combination with Bendamustine Hydrochloride in patients with Hodgkin's lymphoma (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.