Health Trials

Automated Total Marrow and Lymphoid Irradiation for Allogeneic Hematopoietic Cell Transplant

ConditionsAcute Myeloid LeukemiaMyeloproliferative NeoplasmMyelodysplastic Syndromes
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorStanford University

About 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.

Eligibility criteria

Qualifiers

Age 18 to 60 years (inclusive)

HCT Co-Morbidity score (HCT-CI) < 5 (http://www.qxmd.com/calculate-online/hematology/hct-ci)(31)

Adequate performance status is defined as Karnofsky score ≥ 70%

Patients must be receiving an allogeneic peripheral blood stem cell graft

Disqualifiers

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

Trial design

Treatments tested in this trial

  • VMAT-Based Total Marrow and Lymphoid Irradiation (TMLI)
  • Fludarabine
  • Cyclophosphamide
  • Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT)
  • Mycophenolate mofetil (MMF)
  • Tacrolimus

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Stanford University

Lead sponsor

Source ClinicalTrials.gov