Hodgkin LymphomaPhase 2NCT05660993
Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma
A Phase 2 study testing Nivolumab in people with Hodgkin Lymphoma, run by National Research Center for Hematology, Russia at 1 site in Russia.
Trial summary
Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of nivolumab combined with salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hodgkin Lymphoma
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 19 Aug 2019to 1 Mar 2025
- Phase
- Phase 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 Hodgkins lymphoma
- Relapsed or refractory disease after the first line of treatment
- Age 18-70 years old
- Ejection fraction greater than 50%
- ECOG 0-2 status
- 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
- Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
- Karnofsky index <30%
- Pregnancy
- Somatic or psychiatric disorder making the patient unable to sign an informed consent
- Active or prior documented autoimmune disease requiring systemic treatment.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
National Research Center for Hematology
Moscow, 125167
Elena Parovichnikova, 7 (495) 612-23-61, director@blood.ru
About this study
Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of nivolumab combined with salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\r cHL patients. This study evaluates the safety and efficacy of PET-adapted treatment of nivolumab at the 3 mg/kg in combination with Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in patients with relapsed/refractory Hodgkin Lymphoma.
- Conditions
- Hodgkin Lymphoma
- Being tested
- Nivolumab
- Keywords
- PET-adapted Treatment, Relapsed/Refractory Hodgkin Lymphoma, Nivolumab, BeGEV
- 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
Drug: Nivolumab Schedule: Nivolumab 3 mg/kg on day 0 of the Nivo-BeGEV or a maximum of 4 cycles Drug: Bendamustine
Schedule:
Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles Other Name: Ribomustin
Drug: Gemcitabine Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles Other Name: Gemzar
Drug: Vinorelbine Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles Other Name: Navelbine
| Study group | Role | What they receive |
|---|---|---|
| Main arm | Experimental | Patients will receive for a maximum of 4 cycles of nivolumab 3 mg/kg on day 0 BeGEV , with subsequent assessment of response by PET-CT. Patients with CR after 2 cycles Nivo-BeGEV will proceed to ASCT.
Patients with <CR after 2 cycles of a combination Nivo-BeGEV, with subsequent PET-CT assessment, will receive an additional 2 cycles Nivo-BeGEV. Patients with CR after 4 cycles Nivo-BeGEV will proceed to ASCT. Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 Toxicity parameters based on NCI CTCAE 4.03 grades
Measured: 12 months
2. 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 and Lugano 2014 criteria
Measured: 12 months
Secondary outcomes (3)
1. Duration of Response (DOR)
Measured: 24 months
Overall Survival (OS)
Measured: 24 months
Progression-Free Survival (PFS)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start19 Aug 2019
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center for Hematology, Russia
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Elena N.Parovichnikova, National Research Center for Hematology, Russia
- Investigators
- Elena Parovichnikova,, MD,PhD, Study director, Nathional Medical Research Center for Hematology Moscow Russia 125167
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660993
- Sponsor's protocol ID
- r/r cHL-2022
- Status last verified
- Dec 2022
- First submitted
- 13 Dec 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab, Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in Patients With Relapsed/Refractory Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05660993
- Acronym / sponsor ID
- r/r cHL-2022
- Conditions
- Hodgkin Lymphoma
- Keywords
- PET-adapted Treatment, Relapsed/Refractory Hodgkin Lymphoma, Nivolumab, BeGEV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Research Center for Hematology, RussiaResearch network
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 21 Dec 2022 (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.
Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of nivolumab combined with salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\r cHL patients. This study evaluates the safety and efficacy of PET-adapted treatment of nivolumab at the 3 mg/kg in combination with Bendamustine, Gemcitabine, Vinorelbine (Nivo-BeGEV) in patients with relapsed/refractory Hodgkin Lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main arm | Experimental | Drug: NivolumabPatients will receive for a maximum of 4 cycles of nivolumab 3 mg/kg on day 0 BeGEV , with subsequent assessment of response by PET-CT. Patients with CR after 2 cycles Nivo-BeGEV will proceed to ASCT. Patients with <CR after 2 cycles of a combination Nivo-BeGEV, with subsequent PET-CT assessment, will receive an additional 2 cycles Nivo-BeGEV. Patients with CR after 4 cycles Nivo-BeGEV will proceed to ASCT. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis: Histologically confirmed Hodgkins lymphoma
- Relapsed or refractory disease after the first line of treatment
- Age 18-70 years old
- Ejection fraction greater than 50%
- ECOG 0-2 status
Key exclusion criteria (7 listed)
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Requirement for vasopressor support at the time of enrollment
- Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms
- Karnofsky index <30%
- Pregnancy
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 |
|---|---|---|
| NivolumabDrug: Nivolumab Schedule: Nivolumab 3 mg/kg on day 0 of the Nivo-BeGEV or a maximum of 4 cycles Drug: Bendamustine Schedule: Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles Other Name: Ribomustin Drug: Gemcitabine Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles Other Name: Gemzar Drug: Vinorelbine Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles Other Name: Navelbine | Drug | Main arm |
Primary outcome
1. Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 Toxicity parameters based on NCI CTCAE 4.03 grades
Time frame: 12 months
2. 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 and Lugano 2014 criteria
Time frame: 12 months
3 secondary outcomes
1. Duration of Response (DOR)
Time frame: 24 months
Overall Survival (OS)
Time frame: 24 months
Progression-Free Survival (PFS)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
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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.
Elena Parovichnikova,, MD,PhD study director
Nathional Medical Research Center for Hematology Moscow Russia 125167
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab in people with Hodgkin Lymphoma, run by National Research Center for Hematology, Russia 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Dec 2022. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yana Mangasarova, MD (+74956122361, v.k.jana@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 Toxicity parameters based on NCI CTCAE 4.03 grades (time frame: 12 months). The study lists 2 primary outcomes in all. 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 21 Dec 2022.