NCT06812858 PD-1 Inhibitors Maintenance for cHL Post-autoHCT
| NCT ID | NCT06812858 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | St. Petersburg State Pavlov Medical University |
| Condition | Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 83 participants |
| Start Date | 2024-01-09 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 83 participants in total. It began in 2024-01-09 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This phase II study is designed to determine the clinical efficacy of PD-1 inhibitors, administered as maintenance therapy after autologous stem cell transplant (autoHCT), in patients with relapsed or refractory (R/R) classical Hodgkin Lymphoma (cHL)
Eligibility Criteria
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;
Contact & Investigator
Natalia Mikhailova, MD
STUDY CHAIR
St. Petersburg State Pavlov Medical University
Frequently Asked Questions
Who can join the NCT06812858 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06812858 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06812858 currently recruiting?
Yes, NCT06812858 is actively recruiting participants. Contact the research team at md.FedorovaL@gmail.com for enrollment information.
Where is the NCT06812858 trial being conducted?
This trial is being conducted at Astana, Kazakhstan, Moscow, Russia, Moscow, Russia, Saint Petersburg, Russia.
Who is sponsoring the NCT06812858 clinical trial?
NCT06812858 is sponsored by St. Petersburg State Pavlov Medical University. The principal investigator is Natalia Mikhailova, MD at St. Petersburg State Pavlov Medical University. The trial plans to enroll 83 participants.