Hodgkin LymphomaPhase 2Prolgo-HLNCT05757466
Prolgolimab Monotherapy or in Combination With Bendamustine for r/r Classical Hodgkin Lymphoma
A Phase 2 study testing Prolgolimab and Combination with prolgolimab and bendamustine in people with Hodgkin Lymphoma, run by St. Petersburg State Pavlov Medical University at 2 sites in Russia.
Trial summary
Prolgolimab is an anti-PD-1 inhibitor that has previously been shown to be effective and safe for the treatment of patients with melanoma. Given the mechanism of action, it is expected to be effective in patients with classical Hodgkin lymphoma (cHL). 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?
- Prolgolimab and Combination with prolgolimab and bendamustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesRussia
- Study dates
- 19 Apr 2023to 10 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
- Patients with a histologically verified diagnosis of cHL, refractory or relapsed after the first line of therapy
- Age 18-70 y
- Ejection fraction not less than 50%
- No severe concurrent illness
- 0-2 ECOG status
- Use of highly effective contraceptive methods from the moment of signing the informed consent form, throughout the study and within 6 months after receiving the last dose of the drug.
Who cannot join
- Severe organ failure: creatinine > 2 norms; alanine aminotransferase, aspartate aminotransferase > 5 norms; bilirubin> 1.5 norms;
- Respiratory failure > grade 1 at the time of enrollment
- Requirement for vasopressor support at the time of enrollment
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Active or prior documented autoimmune disease requiring systemic treatment
- Pregnancy, breastfeeding, planning pregnancy or parenthood during the study period
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- Hypersensitivity or allergy to study drugs
- Somatic or mental pathology that does not allow to perform research procedures, including the signing of informed consent
- Simultaneous use of drugs or medical devices studied in other clinical trials
- Use of PD-1 inhibitors or bendamustine in the 1st line of therapy
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
St. Petersburg State Pavlov Medical University
Saint Petersburg, 197022
Kirill Lepik, MD, PhD, lepikkv@gmail.com
Liudmila Fedorova, MD, PhD, md.FedorovaL@gmail.com
- Recruiting
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg
Ilya Zyuzgin, ilya.zyuzgin@gmail.com
Stanislav Volchenkov, Stanislav.volchenkov@yahoo.com
About this study
Official title: Efficacy and Safety Study of Second-Line Prolgolimab Monotherapy or in Combination With Bendamustine for Relapsed/Refractory Classical Hodgkin Lymphoma
Prolgolimab is an anti-PD-1 inhibitor that has previously been shown to be effective and safe for the treatment of patients with melanoma. Given the mechanism of action, it is expected to be effective in patients with classical Hodgkin lymphoma (cHL).
The use of PD-1 inhibitors in 2nd line treatment, as part of PET-adapted monotherapy/combination therapy, has already demonstrated a favorable toxicity profile, as well as a high efficacy, which may lead to increased survival of patients with r/r cHL. It has been demonstrated that long-term disease remission can be achieved after PD-1 inhibitor therapy, even in a group of heavily pretreated patients with relapsed/refractory cHL. The use of prolgolimab as part of PET-adapted therapy strategy in this study may allow to achieve a prolonged remission in patients with cHL who are highly sensitive to immunotherapy while omitting the autologous stem cell transplantation.
- Conditions
- Hodgkin Lymphoma
- Being tested
- Prolgolimab, Combination with prolgolimab and bendamustine
- Keywords
- Hodgkin lymphoma, Prolgolimab, PD-1 inhibitors, Bendamustine, Immunotherapy, Relapsed/refractory, Autologous stem cell transplantation,
- Medical subject headings
- Hodgkin Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlgolimabDrug
Prolgolimab monotherapy 1 mg/kg IV every 2 weeks up to a maximum of 24 cycles
Combination with prolgolimab and bendamustineDrug
Prolgolimab 1 mg/kg IV D1,15; Bendamustine 90 mg/m2 IV D1,2, 28-day cycle, maximum of 3 cycles;
| Study group | Role | What they receive |
|---|---|---|
| Main arm | Experimental | Patients receive 6 cycles of prolgolimab monotherapy with subsequent assessment of response by PET/CT using Lugano and LYRIC criteria. Patients with complete response continue prolgolimab therapy for up to 24 cycles. Patients are switched to combination therapy with prolgolimab and chemotherapy (bendamustine) if the complete response is not achieved after 6 cycles of therapy or in case of relapse during prolgolimab monotherapy.
Patients without complete response after 6 cycles of prolgolimab monotherapy or with relapse during monotherapy will receive 3 cycles of combination therapy with prolgolimab and bendamustine every 28 days. Collection of hematopoietic stem cells is performed at any stage of combination therapy. Response evaluation after 3 cycles of combination therapy is performed by PET/CT using Lugano and LYRIC criteria. Autologous stem cell transplantation is conducted in patients who achieve complete or partial response. Receives: Drug: Prolgolimab; Drug: Combination with prolgolimab and bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate during prolgolimab monotherapy
Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by Lugano and LYRIC criteria
Measured: 12 months
Secondary outcomes (6)
Frequency of grade 3 or higher treatment-related adverse events during prolgolimab monotherapy
Toxicity was graded according to NCI CTCAE 5.0.(Common Terminology Criteria for Adverse Events Version 5.0)
Measured: 12 months
Frequency of grade 3 or higher treatment-related adverse events during combination therapy (prolgolimab+bendamustine)
Toxicity was graded according to NCI CTCAE 5.0.(Common Terminology Criteria for Adverse Events Version 5.0)
Measured: 24 months
Overall response rate during combination therapy (prolgolimab+bendamustine)
Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by Lugano and LYRIC criteria
Measured: 24 months
1-year and 2-year overall survival
Overall survival defined as the time from the protocol therapy initiation to death from any reason
Measured: 24 months
1-year and 2-year progression-free survival
Progression-free survival defined as the time from the protocol therapy initiation to disease progression, relapse or death from any reason.
Measured: 24 months
Duration of response
Duration of response was defined as the time from response achievement to disease progression, relapse or death from any reason
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 posted7 Mar 2023
- Study start19 Apr 2023
- Primary completion10 Mar 2024 (estimated)
- Study completion10 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg State Pavlov Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- N.N. Petrov National Medical Research Center of Oncology
- Responsible party
- Principal investigator, Ivan S Moiseev, St. Petersburg State Pavlov Medical University
- Investigators
- Kirill Lepik, MD, PhD, Principal investigator, St. Petersburg State Pavlov Medical UniversityNatalia Mikhailova, MD, Study chair, St. Petersburg State Pavlov Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757466
- Sponsor's protocol ID
- 27/22-н
- Acronym
- Prolgo-HL
- Status last verified
- Dec 2023
- First submitted
- 17 Feb 2023
- Last updated
- 19 Dec 2023
- 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 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Second-Line Prolgolimab Monotherapy or in Combination With Bendamustine for Relapsed/Refractory Classical Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05757466
- Acronym / sponsor ID
- Prolgo-HL / 27/22-н
- Conditions
- Hodgkin Lymphoma
- Keywords
- Hodgkin lymphoma, Prolgolimab, PD-1 inhibitors, Bendamustine, Immunotherapy, Relapsed/refractory, Autologous stem cell transplantation,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St. Petersburg State Pavlov Medical UniversityUniversity, hospital or other
- Collaborators
- N.N. Petrov National Medical Research Center of Oncology
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 10 Mar 2024 (estimated)
- Study completion
- 10 Mar 2025 (estimated)
- First posted
- 7 Mar 2023 (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.
Prolgolimab is an anti-PD-1 inhibitor that has previously been shown to be effective and safe for the treatment of patients with melanoma. Given the mechanism of action, it is expected to be effective in patients with classical Hodgkin lymphoma (cHL).
The use of PD-1 inhibitors in 2nd line treatment, as part of PET-adapted monotherapy/combination therapy, has already demonstrated a favorable toxicity profile, as well as a high efficacy, which may lead to increased survival of patients with r/r cHL. It has been demonstrated that long-term disease remission can be achieved after PD-1 inhibitor therapy, even in a group of heavily pretreated patients with relapsed/refractory cHL. The use of prolgolimab as part of PET-adapted therapy strategy in this study may allow to achieve a prolonged remission in patients with cHL who are highly sensitive to immunotherapy while omitting the autologous stem cell transplantation.
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: Prolgolimab, Drug: Combination with prolgolimab and bendamustinePatients receive 6 cycles of prolgolimab monotherapy with subsequent assessment of response by PET/CT using Lugano and LYRIC criteria. Patients with complete response continue prolgolimab therapy for up to 24 cycles. Patients are switched to combination therapy with prolgolimab and chemotherapy (bendamustine) if the complete response is not achieved after 6 cycles of therapy or in case of relapse during prolgolimab monotherapy. Patients without complete response after 6 cycles of prolgolimab monotherapy or with relapse during monotherapy will receive 3 cycles of combination therapy with prolgolimab and bendamustine every 28 days. Collection of hematopoietic stem cells is performed at any stage of combination therapy. Response evaluation after 3 cycles of combination therapy is performed by PET/CT using Lugano and LYRIC criteria. Autologous stem cell transplantation is conducted in patients who achieve complete or partial response. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a histologically verified diagnosis of cHL, refractory or relapsed after the first line of therapy
- Age 18-70 y
- Ejection fraction not less than 50%
- No severe concurrent illness
- 0-2 ECOG status
Key exclusion criteria (10 listed)
- Severe organ failure: creatinine > 2 norms; alanine aminotransferase, aspartate aminotransferase > 5 norms; bilirubin> 1.5 norms;
- Respiratory failure > grade 1 at the time of enrollment
- Requirement for vasopressor support at the time of enrollment
- Uncontrolled bacterial or fungal infection at the time of enrollment
- Active or prior documented autoimmune disease requiring systemic treatment
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 |
|---|---|---|
| ProlgolimabProlgolimab monotherapy 1 mg/kg IV every 2 weeks up to a maximum of 24 cycles | Drug | Main arm |
| Combination with prolgolimab and bendamustineProlgolimab 1 mg/kg IV D1,15; Bendamustine 90 mg/m2 IV D1,2, 28-day cycle, maximum of 3 cycles; | Drug | Main arm |
Primary outcome
Overall response rate during prolgolimab monotherapy
Time frame: 12 months
Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by Lugano and LYRIC criteria
6 secondary outcomes
Frequency of grade 3 or higher treatment-related adverse events during prolgolimab monotherapy
Time frame: 12 months
Frequency of grade 3 or higher treatment-related adverse events during combination therapy (prolgolimab+bendamustine)
Time frame: 24 months
Overall response rate during combination therapy (prolgolimab+bendamustine)
Time frame: 24 months
1-year and 2-year overall survival
Time frame: 24 months
1-year and 2-year progression-free survival
Time frame: 24 months
Duration of response
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 19 Dec 2023.
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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.
Kirill Lepik, MD, PhD principal investigator
St. Petersburg State Pavlov Medical University
Natalia Mikhailova, MD study chair
St. Petersburg State Pavlov Medical University
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 Prolgolimab and Combination with prolgolimab and bendamustine in people with Hodgkin Lymphoma, 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 6 inclusion and 10 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 19 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kirill Lepik, MD, PhD (+78123386265, lepikkv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate during prolgolimab monotherapy (time frame: 12 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 19 Dec 2023.