Automated Total Marrow and Lymphoid Irradiation for Allogeneic Hematopoietic Cell Transplant

Summary

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.

Eligibility

Age range

18–70 years

Sex

All

Healthy volunteers

No

Interventions

• Radiation
  VMAT-Based Total Marrow and Lymphoid Irradiation (TMLI)

  Patients receive VMAT-based TMLI with daily image-guided radiation therapy (IGRT) for treatment localization and verification prior to radiation delivery.

• Drug
  Fludarabine

  Fludarabine 25 mg/m² IV administered daily on Days -7 through -3.

• Drug
  Cyclophosphamide

  Cyclophosphamide 14.5 mg/kg IV on Days -7 and -6 as part of conditioning and 50 mg/kg IV on Days +3 and +4 as post-transplant GVHD prophylaxis.

• Biological
  Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT)

  Allogeneic peripheral blood stem cell transplantation administered on Day 0.

• Drug
  Mycophenolate mofetil (MMF)

  Mycophenolate mofetil initiated on Day +5 and continued through Day +35 for GVHD prophylaxis.

• Drug
  Tacrolimus

Location