Relapsed or Refractory Hodgkin LymphomaPhase 2NCT06931613
Autologous Hematopoietic Stem Cell Transplantation in Pediatric Relapsed or Refractory Hodgkin Lymphoma After Nivolumab Treatment
A Phase 2 study testing Nivolumab in people with Relapsed or Refractory Hodgkin Lymphoma and Children, run by St. Petersburg State Pavlov Medical University at 2 sites in Russia.
Trial summary
Children with relapsed or refractory Hodgkin lymphoma receive 3-6 cycles of nivolumab monotherapy. In case of achieving complete response (CR) auto-HSCT is performed. In the absence of CR, 3-6 additional cycles of nivolumab with bendamustine are administered. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Relapsed or Refractory Hodgkin Lymphoma, Children, Nivolumab
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Jun 2022to 1 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Hodgkin lymphoma established on the basis of histological and immunohistochemical studies
- Confirmation of relapsed of refractory Hodgkin lymphoma based on histological and immunohistochemical studies or based on imaging methods (PET/CT and/or CT).
- Number of previous lines of therapy >2
- Karnofsky index ≥60%
- availability of signed informed consent -
Who cannot join
- Number of previous lines of therapy ≤ 2
- Karnofsky index < 60
- Intolerance to drugs used in the study
- Presence of a second tumor
- Pregnancy or lactation
- Participation in another study within six months
- Presence of concomitant severe disease
- Presence of HIV and/or viral hepatitis (B or C)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia2 sites
N. N. Blokhin Russian Cancer Research Center, Moscow, Russia
Moscow
Pavlov University, RM Gorbacheva Research Institute
Saint Petersburg, 196022
About this study
Official title: Autologous Hematopoietic Stem Cell Transplantation in Pediatric Relapsed or Refractory Hodgkin Lymphoma After Nivolumab Treatment With or Without Bendamustine
Children with relapsed or refractory Hodgkin lymphoma receive 3-6 cycles of nivolumab monotherapy. In case of achieving complete response (CR) auto-HSCT is performed. In the absence of CR, 3-6 additional cycles of nivolumab with bendamustine are administered. If complete or partial response is achieved, auto-HSCT is performed.
- Conditions
- Relapsed or Refractory Hodgkin Lymphoma, Children, Nivolumab, Autologous Haemopoietic Stem Cell Transplant
- Being tested
- Nivolumab
- Medical subject headings
- Recurrence, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called bendamustine, autologous hematopoietic stem cell transplantation
Nivolumab with or without bendamustine is administered to children prior to auto-HSCT
| Study group | Role | What they receive |
|---|---|---|
| The only ARM consists of nivolumab with or without bendamustine prior to auto-HSCT | Experimental | Not described Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
Measured: 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start1 Jun 2022
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory 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
- 20 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931613
- Sponsor's protocol ID
- 34/19-н
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 17 Apr 2025
- 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 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Hematopoietic Stem Cell Transplantation in Pediatric Relapsed or Refractory Hodgkin Lymphoma After Nivolumab Treatment With or Without Bendamustine
- ClinicalTrials.gov ID
- NCT06931613
- Acronym / sponsor ID
- 34/19-н
- Conditions
- Relapsed or Refractory Hodgkin Lymphoma, Children, Nivolumab, Autologous Haemopoietic Stem Cell Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 17 Apr 2025 (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.
Children with relapsed or refractory Hodgkin lymphoma receive 3-6 cycles of nivolumab monotherapy. In case of achieving complete response (CR) auto-HSCT is performed. In the absence of CR, 3-6 additional cycles of nivolumab with bendamustine are administered. If complete or partial response is achieved, auto-HSCT is performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The only ARM consists of nivolumab with or without bendamustine prior to auto-HSCT | Experimental | Drug: Nivolumab |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosis of Hodgkin lymphoma established on the basis of histological and immunohistochemical studies
- Confirmation of relapsed of refractory Hodgkin lymphoma based on histological and immunohistochemical studies or based on imaging methods (PET/CT and/or CT).
- Number of previous lines of therapy >2
- Karnofsky index ≥60%
- availability of signed informed consent -
Key exclusion criteria (8 listed)
- Number of previous lines of therapy ≤ 2
- Karnofsky index < 60
- Intolerance to drugs used in the study
- Presence of a second tumor
- Pregnancy or lactation
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: bendamustine, autologous hematopoietic stem cell transplantationNivolumab with or without bendamustine is administered to children prior to auto-HSCT | Drug | The only ARM consists of nivolumab with or without bendamustine prior to auto-HSCT |
Primary outcome
Event free survival
Time frame: 5-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Relapsed or Refractory Hodgkin Lymphoma and Children, run by St. Petersburg State Pavlov Medical University at 2 sites 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 5 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Event free survival (time frame: 5-year). 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 17 Apr 2025.