Automated TMLI for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
Intensive conditioning regimens used in allogeneic hematopoietic cell transplant (HCT) help to eliminate hematologic tumors and reduce the risk of relapse, but are also characterized by high toxicity. Total marrow and lymphoid irradiation (TMLI) is a specialized radiation technique that specifically targets marrow and lymphoid tissue to maximize antitumor efficacy while reducing off target toxicity. Despite these benefits, TMLI is technically challenging and time consuming. The radiation oncology team at Stanford has developed an automated TMLI platform to overcome these challenges. In this phase II trial, automation will be incorporated into a previously validated conditioning regimen of fludarabine/cyclophosphamide/TMLI HCT with post-transplant cyclophosphamide (PTCy) for graft-versus-host disease (GVHD) prophylaxis to confirm the feasibility and safety of automation in patients receiving allogeneic HCT for high-risk myeloid malignancies.
Who Is on the Research Team?
Hany Elmariah, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for adults aged 18-60 with high-risk blood cancers like acute myeloid leukemia or myelodysplastic syndrome, who are healthy enough for a stem cell transplant and have an eligible donor match. Participants must meet certain health criteria and performance status.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Conditioning
Participants receive fludarabine, cyclophosphamide, and TMLI conditioning followed by allogeneic peripheral blood stem cell transplantation
Post-transplant GVHD Prophylaxis
Participants receive post-transplant GVHD prophylaxis including cyclophosphamide, mycophenolate mofetil, and tacrolimus
Follow-up
Participants are monitored for safety and effectiveness after transplantation, including assessment of non-relapse mortality, neutrophil engraftment, and incidence of GVHD
What Are the Treatments Tested in This Trial?
Interventions
- VMAT-Based Total Marrow and Lymphoid Irradiation (TMLI)
Trial Overview
The study tests an automated radiation technique (TMLI) combined with chemotherapy drugs (fludarabine, cyclophosphamide), followed by a stem cell transplant from a donor. Additional medications help prevent complications after the transplant.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants receive fludarabine, cyclophosphamide, and TMLI 150 cGy BID conditioning followed by allogeneic peripheral blood stem cell transplantation (PBSCT). Post-transplant GVHD prophylaxis includes cyclophosphamide, mycophenolate mofetil, and tacrolimus.
Participants receive fludarabine, cyclophosphamide, and TMLI 200 cGy BID conditioning followed by allogeneic peripheral blood stem cell transplantation (PBSCT). Post-transplant GVHD prophylaxis includes cyclophosphamide, mycophenolate mofetil, and tacrolimus.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
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