Automated Total Marrow and Lymphoid Irradiation for Allogeneic Hematopoietic Cell Transplant
Starting soon · Phase 2
Conditions studied: Acute Myeloid Leukemia, Myeloproliferative Neoplasm, Myelodysplastic Syndromes
In brief
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.
Key facts
- Study ID
- NCT07634536
- Run by
- Stanford University
- People needed
- 30
- Starts
- 2026-08-01
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2026-06-09
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.
- Untreated active infection. Controlled or asymptomatic infections requiring continued antimicrobial therapy are permissible.
- Active HIV infection, defined as HIV infection with detectable viral load
- Active central nervous system malignancy
- GVHD requiring systemic therapy including > 0.25 mg/kg prednisone (or equivalent) or other systemic therapy for GVHD (e.g., tacrolimus, sirolimus, ruxolitinib, belumosodil, ibrutinib, axatilimab).
- Any other medical or psychological condition that is deemed serious and unsafe for clinical trial participation.
- Exposure to prior radiation that is deemed unsafe for clinical trial participation.
Where it is running
- Stanford University — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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