New hope for hodgkin lymphoma: maintenance drug after transplant
NCT ID NCT06812858
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a drug called a PD-1 inhibitor can help keep Hodgkin lymphoma from coming back after a stem cell transplant. It is for people whose lymphoma returned or did not respond to earlier treatments. About 83 adults will receive the drug as maintenance therapy and be followed for up to 2 years to see if it improves cancer control.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 83 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 18-70 years; * Diagnosis of r/r cHL with auto-HCT being performed as consolidation of 2 or later therapy lines; * High-risk cHL (Primary refractoriness after first-line therapy / Relapse after first line therapy within 12 months / PET/CT-positive status at the time of auto-HCT / Late relapse (\> 12 months) with unfavourable prognosis factors (extranodal lesion and/or bulky and/or B-symptoms) / More than one salvage regimen performed) * Complete or partial response by PET/CT after auto-HSCT * No evidence of grade 3-4 adverse events (CTCAEs) after auto-HCT at the time of inclusion in the study; * Achieved recovery of peripheral blood counts after auto-HSCT (white blood cell count\> 1 109/L, absolute neutrophil count\> 0.5 109/L, platelets \> 25 109/L); * ECOG 0-2; The decision to include patients that do not fulfil the criteria of hight-risk cHL is made in consultation with the PI Exclusion Criteria: * Patients who have received PD1-inhibitor therapy in the previous lines of treatment and had to interrupt treatment early due to the development of adverse events of therapy; * Severe organ failure: creatinine values more than 2 ULN; ALT, AST more than 5 ULN; bilirubin more than 1.5 ULN; * Respiratory failure of more than 1 degree at the time of inclusion in the study; * Unstable haemodynamics at the time of inclusion in the study; * Acute bacterial, viral or fungal infection at the time of inclusion; * Active autoimmune diseases (subjects with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, and skin diseases such as vitiligo, allopecia, or psoriasis that do not require systemic therapy may be eligible); * Pregnancy or breastfeeding, or planning pregnancy or parenthood during the study period; * Somatic or psychiatric pathology that prevents the signing of informed consent;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Medical and Surgical Center named after N.I. Pirogov
RECRUITINGMoscow, Russia
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National Research Oncology Center
RECRUITINGAstana, Kazakhstan
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RM Gorbacheva Research Institute, Pavlov University
RECRUITINGSaint Petersburg, Russia
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RecruitingP. Hertsen Moscow Oncology Research Institute (MORI) for administrative and economic work - the branch of the FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation
RECRUITINGMoscow, Russia
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Other studies related to the condition(s) this trial covers.
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