Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06812858

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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