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

St. Petersburg State Pavlov Medical University

Status and phase: Invitation-only; Phase 2

Conditions: Relapsed or Refractory Hodgkin Lymphoma; Autologous Haemopoietic Stem Cell Transplant; Children; Nivolumab

Treatments: Drug: Nivolumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06931613

34/19-н

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Hodgkin lymphoma established on the basis of histological and immunohistochemical studies
• Confirmation of relapsed of refractory Hodgkin lymphoma based on histological and immunohistochemical studies or based on imaging methods (PET/CT and/or CT).
• Number of previous lines of therapy >2
• Karnofsky index ≥60%
• availability of signed informed consent -

Exclusion criteria

• Number of previous lines of therapy ≤ 2
• Karnofsky index < 60
• Intolerance to drugs used in the study
• Presence of a second tumor
• Pregnancy or lactation
• Participation in another study within six months
• Presence of concomitant severe disease
• Presence of HIV and/or viral hepatitis (B or C)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

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

Experimental group

Treatment:

Drug: Nivolumab