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Automated Total Marrow and Lymphoid Irradiation for Allogeneic Hematopoietic Cell Transplant

NCT07634536 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-09

No results posted yet for this study

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.

Conditions

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

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

Sponsors & Collaborators

Principal Investigators

  • Hany Elmariah, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07634536 on ClinicalTrials.gov