Primary Mediastinal (Thymic) Large B-cell LymphomaPhase 1/2NCT06871007
Nivolumab and DA-EPOCH-R in Pediatric Primary Mediastinal (Thymic) Large B-cell Lymphoma
A Phase 1/2 study testing Nivolumab in people with Primary Mediastinal (Thymic) Large B-cell Lymphoma and Children, run by St. Petersburg State Pavlov Medical University at 2 sites in Russia.
Trial summary
Addition of nivolumab (immune checkpoint inhibitor) to standard chemotherapy (DA-EPOCH-R) may improve outcome in children with primary mediastinal large B-cell lymphoma Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Primary Mediastinal (Thymic) Large B-cell Lymphoma, Children, Nivolumab
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Sep 2024to 1 Sep 2031
- Phase
- Phase 1/2
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age from 0 years to 17 years 11 months
- Established on the basis of histological and immunohistochemical studies, the diagnosis of PMLBL (the presence of programmed death-ligand on tumor cells is not necessary)
- Lack of specific therapy for lymphoma
- Signed informed consent
Who cannot join
- Age >18
- History of specific therapy for lymphomas.
- Drug intolerance
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
Dmitry Rogachev National Research Center
Moscow
Pavlov University, RM Gorbacheva Research Institute
Saint Petersburg, 196022
About this study
Addition of nivolumab (immune checkpoint inhibitor) to standard chemotherapy (DA-EPOCH-R) may improve outcome in children with primary mediastinal large B-cell lymphoma
Read the detailed description
A total of 6 blocks of Nivolumab+DA-EPOCH-R are planned for all patients regardless of stage and other risk factors. Nivolumab 40 mg (Day 2), Rituximab 375 mg/m2 (Day 1) and Prednisolone 60 mg/m2 (Days 1-5) are administered at constant unchangeable doses. Other drugs are administered at starting doses (Etoposide 50 mg/m2 (Days 1-4), Doxorubicin 10 mg/m2 (Days 1-4), Vincristine 0,4 mg/m2 (Days 1-4) and Cyclophosphamide 750 mg/m2 (Day 5). These starting doses are adjusted further according to standard principles of DA-EPOCH-R.
- Being tested
- Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Etoposide, Doxorubicin, Vincristine, Cyclophosphamide
Nivolumab 40 mg on Day 2 is added to dose-adjusted EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab; DA-EPOCH-R).Standard guidelines for conducting the DA-EPOCH-R protocol will be used.
| Study group | Role | What they receive |
|---|---|---|
| The only ARM consists of nivolumab combined with DA-EPOCH-R protocol | Other | Children with PMLBL will receive standard chemotherapy (dose-adjusted EPOCH-R) combined with nivolumab 40 mg on Day 2 Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
Kaplan-Meyer estimate
Measured: 5 year
Secondary outcomes (2)
Overall survival
Kaplan-Meyer estimate
Measured: 5 year
Progression free survival
Kaplan-Meyer estimate
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 posted11 Mar 2025
- Study start1 Sep 2024
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Mediastinal (Thymic) Large B-cell 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
- 22 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
- Investigators
- Natalya Myakova, Principal investigator, Dmitry Rogachev National Research CenterLudmila Zubarovskaya, Principal investigator, Pavlov University, R.M. Gorbacheva Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871007
- Sponsor's protocol ID
- 290
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nivolumab and DA-EPOCH-R in Pediatric Primary Mediastinal (Thymic) Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06871007
- Acronym / sponsor ID
- 290
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 11 Mar 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.
Addition of nivolumab (immune checkpoint inhibitor) to standard chemotherapy (DA-EPOCH-R) may improve outcome in children with primary mediastinal large B-cell lymphoma
Detailed description
A total of 6 blocks of Nivolumab+DA-EPOCH-R are planned for all patients regardless of stage and other risk factors. Nivolumab 40 mg (Day 2), Rituximab 375 mg/m2 (Day 1) and Prednisolone 60 mg/m2 (Days 1-5) are administered at constant unchangeable doses. Other drugs are administered at starting doses (Etoposide 50 mg/m2 (Days 1-4), Doxorubicin 10 mg/m2 (Days 1-4), Vincristine 0,4 mg/m2 (Days 1-4) and Cyclophosphamide 750 mg/m2 (Day 5). These starting doses are adjusted further according to standard principles of DA-EPOCH-R.
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 combined with DA-EPOCH-R protocol | Other | Drug: NivolumabChildren with PMLBL will receive standard chemotherapy (dose-adjusted EPOCH-R) combined with nivolumab 40 mg on Day 2 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age from 0 years to 17 years 11 months
Key exclusion criteria (3 listed)
- Age >18
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: Etoposide, Doxorubicin, Vincristine, CyclophosphamideNivolumab 40 mg on Day 2 is added to dose-adjusted EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab; DA-EPOCH-R).Standard guidelines for conducting the DA-EPOCH-R protocol will be used. | Drug | The only ARM consists of nivolumab combined with DA-EPOCH-R protocol |
Primary outcome
Event free survival
Time frame: 5 year
Kaplan-Meyer estimate
2 secondary outcomes
Overall survival
Time frame: 5 year
Progression 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 11 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Primary Mediastinal (Thymic) Large B-cell Lymphoma
Active, not recruitingPhase 1
Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.
Grade 3b Follicular Lymphoma, Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between DLBCL and Classic HL
RecruitingPhase 2
Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Diffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma
RecruitingPhase 2
Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Grade 3b Follicular Lymphoma
Active, not recruitingPhase 1/2
ALX148, Rituximab and Lenalidomide for the Treatment of Indolent and Aggressive B-cell Non-Hodgkin Lymphoma
Aggressive B-Cell Non-Hodgkin Lymphoma, Ann Arbor Stage III Grade 2 Follicular Lymphoma
Active, not recruitingPhase 2
Polatuzumab Vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-ICE) as Initial Salvage Therapy for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma Unclassifiable, Recurrent Diffuse Large B-Cell Lymphoma
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.
Natalya Myakova principal investigator
Dmitry Rogachev National Research Center
Ludmila Zubarovskaya principal investigator
Pavlov University, R.M. Gorbacheva Research Institute
2 sites 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 in people with Primary Mediastinal (Thymic) Large B-cell 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 4 inclusion and 3 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 11 Mar 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 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?
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 11 Mar 2025.