Nivolumab and DA-EPOCH-R in Pediatric Primary Mediastinal (Thymic) Large B-cell Lymphoma

Sponsor
St. Petersburg State Pavlov Medical University
Study ID
NCT06871007
Phase
PHASE1/PHASE2
Status
Enrolling By Invitation

Conditions

  • Children
  • Nivolumab
  • Primary Mediastinal (Thymic) Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab 40 mg on Day 2 is added to dose-adjusted EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab; DA-EPOCH-R).Standard guidelines for conducting the DA-EPOCH-R protocol will be used.

Study Details

Addition of nivolumab (immune checkpoint inhibitor) to standard chemotherapy (DA-EPOCH-R) may improve outcome in children with primary mediastinal large B-cell lymphoma

Key Dates

Start date
Sep 1, 2024
Status verified
Mar 2025
Primary completion
Sep 1, 2029
Completion
Sep 1, 2031

Study Design

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

Arms

  • Other: The only ARM consists of nivolumab combined with DA-EPOCH-R protocol
    Children with PMLBL will receive standard chemotherapy (dose-adjusted EPOCH-R) combined with nivolumab 40 mg on Day 2

Primary Outcome Measure

Event free survival [ Time Frame: 5 year ]

Related Studies