Actively Recruiting
PD-1 Inhibitors Maintenance for cHL Post-autoHCT
Led by St. Petersburg State Pavlov Medical University · Updated on 2026-04-30
83
Participants Needed
4
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
PD-1 Inhibitors Maintenance for cHL Post-autoHCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Diagnosis of relapsed or refractory classical Hodgkin lymphoma with autologous hematopoietic stem cell transplant performed as consolidation after two or more therapy lines
- High-risk classical Hodgkin lymphoma defined by specific relapse or refractory criteria
- Complete or partial response by PET/CT after transplant
- No grade 3-4 adverse events after transplant at study entry
- Recovery of peripheral blood counts after transplant (white blood cells > 1 x 10^9/L, neutrophils > 0.5 x 10^9/L, platelets > 25 x 10^9/L)
- ECOG performance status between 0 and 2
- Inclusion of patients not meeting high-risk criteria may be considered with investigator consultation
You will not qualify if you...
- Prior treatment with PD-1 inhibitors interrupted early due to adverse events
- Severe organ failure (creatinine > 2 times upper limit of normal, ALT or AST > 5 times upper limit, bilirubin > 1.5 times upper limit)
- Respiratory failure greater than grade 1 at study entry
- Unstable hemodynamics at study entry
- Active acute bacterial, viral, or fungal infection at study entry
- Active autoimmune diseases requiring systemic therapy (exceptions include certain hormone replacement and mild skin conditions)
- Pregnancy, breastfeeding, or planning pregnancy or parenthood during study
- Medical or psychiatric conditions preventing informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
National Research Oncology Center
Astana, Kazakhstan
Actively Recruiting
2
National Medical and Surgical Center named after N.I. Pirogov
Moscow, Russia
Actively Recruiting
3
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
Moscow, Russia
Actively Recruiting
4
RM Gorbacheva Research Institute, Pavlov University
Saint Petersburg, Russia
Actively Recruiting
Research Team
P
Polina Kotseliabina, MD
CONTACT
L
Liudmila Fedorova, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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