Autologous Hematopoietic Stem Cell Transplantation in Pediatric Relapsed or Refractory Hodgkin Lymphoma After Nivolumab Treatment

Sponsor
St. Petersburg State Pavlov Medical University
Study ID
NCT06931613
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Autologous Haemopoietic Stem Cell Transplant
  • Children
  • Nivolumab
  • Relapsed or Refractory Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab with or without bendamustine is administered to children prior to auto-HSCT

Study Details

Children with relapsed or refractory Hodgkin lymphoma receive 3-6 cycles of nivolumab monotherapy. In case of achieving complete response (CR) auto-HSCT is performed. In the absence of CR, 3-6 additional cycles of nivolumab with bendamustine are administered. If complete or partial response is achieved, auto-HSCT is performed.

Key Dates

Start date
Jun 1, 2022
Status verified
Apr 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: The only ARM consists of nivolumab with or without bendamustine prior to auto-HSCT

Primary Outcome Measure

Event free survival [ Time Frame: 5-year ]

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