Automated Total Marrow and Lymphoid Irradiation for Allogeneic Hematopoietic Cell Transplant

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07634536
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • VMAT-Based Total Marrow and Lymphoid Irradiation (TMLI) — RADIATION
    Patients receive VMAT-based TMLI with daily image-guided radiation therapy (IGRT) for treatment localization and verification prior to radiation delivery.
  • Fludarabine — DRUG
    Fludarabine 25 mg/m² IV administered daily on Days -7 through -3.
  • Cyclophosphamide — DRUG
    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.
  • Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) — BIOLOGICAL
    Allogeneic peripheral blood stem cell transplantation administered on Day 0.
  • Mycophenolate mofetil (MMF) — DRUG
    Mycophenolate mofetil initiated on Day +5 and continued through Day +35 for GVHD prophylaxis.
  • Tacrolimus — DRUG
    Mycophenolate mofetil initiated on Day +5 and continued through Day +35 for GVHD prophylaxis.

Study Details

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 Dates

Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Total Marrow and Lymphoid Irradiation (TMLI) 200 cGy BID Conditioning Regimen
    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.
  • Experimental: Cohort B: Total Marrow and Lymphoid Irradiation 150 cGy BID Conditioning Regimen
    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.

Primary Outcome Measure

Non-Relapse Mortality (NRM) [ Time Frame: Day 100 after transplantation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Hany Elmariah, MD
[email protected]
650-723-0822
Hany Elmariah, MD (PRINCIPAL_INVESTIGATOR)

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