Actively Recruiting
Allogeneic Stem Cell Transplantation Using Alpha/Beta T Cell and CD19+ B Cell Depletion with Zoledronic Acid to Treat Pediatric, Adolescent, and Young Adult Patients with Relapsed or Refractory Solid Tumors
Led by University of Florida · Updated on 2026-03-11
27
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new treatment approach for pediatric and young adult patients with relapsed or refractory solid tumors. The study focuses on using allogeneic stem cell transplantation that removes alpha/beta T cells and CD19+ B cells to reduce complications like graft-versus-host disease and improve outcomes. This approach is combined with zoledronic acid to potentially enhance the immune system's ability to fight tumors and improve survival rates. Participants will receive a stem cell transplant processed with the Miltenyi CliniMACS Prodigy® system to remove specific immune cells. Zoledronic acid will be given intravenously on days 28, 56, 84, 112, and 140 after transplant. The study includes a phase Ib dose-finding segment and a phase II segment to evaluate the safest and most effective dose of zoledronic acid. During the study, participants will be closely monitored for disease-free survival at 1 year post-transplant and the incidence of acute graft-versus-host disease over 2 years. Additional survival rates will be assessed at 100 days, 1 year, and 2 years. Assessments include clinical evaluations and safety monitoring over several years, with the total participation lasting until 2 years post-transplant to evaluate long-term effects and outcomes.
CONDITIONS
Brief Title
Alpha/Beta T and B Cell Depletion With Zoledronic Acid for Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 6 months to 25 years
- Relapsed or refractory solid tumor with failure or ineligibility for autologous transplant or less than 20% cure chance with autologous transplant
- Diagnosis includes neuroblastoma, rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcomas, high-risk adult-type soft tissue sarcomas, other high-risk extracranial solid tumors, relapsed/refractory bone tumors, or other high-risk solid tumors with expected survival under 10%
- No more than one active malignancy at enrollment
- Haplo-identical related donor with at least one full haplotype matched
- Karnofsky or Lansky score of 60% or higher
- Adequate organ function within 4 weeks before preparative regimen
- Informed consent obtained and agreement to comply with study procedures
- Individuals of childbearing potential must use effective contraception during study and for one year after transplant
You will not qualify if you...
- Uncontrolled infection at study entry
- Lack of compliance with medical care
- Received allogeneic hematopoietic stem cell transplant within 6 months
- No eligible allogeneic donor available
- Life expectancy less than 3 months
- Failure to meet organ function inclusion criteria
- Unwilling or unable to use contraception during study and for one year after transplant
- Pregnant or breastfeeding females
- Any other condition that contraindicates protocol therapy or increases risk, as determined by physician
- Prisoners or involuntarily incarcerated individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate post-transplant care
Participants receive an allogeneic stem cell transplant that has been depleted of alpha/beta T-cells and CD19+ B-cells using the Miltenyi CliniMACS Prodigy® system.
1 transplant procedure visit and several immediate post-transplant monitoring visits
Duration - Approximately 20 weeks
Participants receive intravenous zoledronic acid on days +28, +56, +84, +112, and +140 following the transplant.
5 intravenous dosing visits
Duration - Up to 2 years
Participants are monitored for disease-free survival, overall survival, and incidence of acute graft-versus-host disease for up to 2 years post-transplant.
Regular follow-up visits for health assessments and monitoring
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
G
Giselle Moore-Higgs, PhD, APRN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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