20
Participants
Start Date
August 7, 2025
Primary Completion Date
July 1, 2029
Study Completion Date
July 1, 2030
Vinblastine (Velban)
Low risk cohort patients will receive 2 cycles of Induction therapy with single-drug vinBLAStine (VBL), then undergo disease assessment. If complete remission (CR) and MRD -, LR patients will continue single-drug VBL for a total of 24 months (if absent disease progression or unacceptable toxicity).
Brentuximab vedotin (Adcetris)
HR cohort patients with no previous exposure to BV will receive 2 cycles of Induction therapy with BV and NIVO \[BV + NIVO\] one every 21 days, then undergo disease assessment. Patients in CR will proceed with consolidation with RTC allogeneic SCT (SCT)\*. If patient has any response other than CR and MRD-, they will receive 2 cycles of BV, VBL, and NIVO \[BV + VBL + NIVO\] once every 21 days
Nivolumab (Opdivo)
High risk cohort patients with previous exposure to Brentuximab vedotin (BV) will receive 2 cycles of Induction therapy with VBL and NIVO \[VBL + NIVO\] on day 1 and 15, then undergo disease assessment. If response is not CR, or patient has PR/SD/PD, patient will receive \[BV+VBL+NIVO\] and subsequent therapy as defined for the HR2 cohort.
New York Medical College, Valhalla
Lead Sponsor
University of Alabama at Birmingham
OTHER
Helen DeVos Children's Hospital
OTHER
Nationwide Children's Hospital
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
University of Utah
OTHER
Ohio State University
OTHER
University of North Carolina
OTHER
Children's Hospital of Philadelphia
OTHER
Medical College of Wisconsin
OTHER
Children's Hospital of Orange County
OTHER
New York Medical College
OTHER