Fludarabine and Total Body Irradiation 800 Centigray (cGy) or 1125 cGy For Allogeneic Stem Cell Transplant Using Graft Versus Host Disease Prophylaxis With Post-Transplant Cyclophosphamide and Tacrolimus, Without Mycophenolate Mofetil

Last updated: April 1, 2025
Sponsor: Ronald Paquette
Overall Status: Active - Not Recruiting

Phase

2

Condition

Hematologic Neoplasms

Treatment

Omission of the drug mycophenolate mofetil

Clinical Study ID

NCT05256537
IIT2021-11-PAQUETTE-OmitMMF
  • Ages 18-75
  • All Genders

Study Summary

This is a pilot study to evaluate the feasibility, safety and potential benefits of removing one immune suppressive drug called mycophenolate mofetil (MMF) from the standard allogenic stem cell transplant treatment protocol.

MMF will be omitted from the transplant regimen in 60 eligible patients with hematologic malignancies. Participants will be followed for up to 2 years post standard of care transplant at Cedars-Sinai.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient age 18-75 years

  • Patient has a related donor who is at least Human Leukocyte Antigen (HLA)haploidentical, or an unrelated donor who is a most a single HLA antigen mismatch.

  • Patient signs the Informed Consent Form for the study

  • Patient has a hematologic malignancy other than myelofibrosis and meets standardcriteria for allogeneic stem cell transplant.

  • Patient is deemed suitable to receive Fludarabine and Total Body Irradiation (Flu/TBI) 1125 or Flu/TBI 800 conditioning regimen as standard of care transplant

  • Donor is willing to donate peripheral blood stem cells

Exclusion

Exclusion Criteria:

  • Patient has a diagnosis of myelofibrosis

  • Patient has high titer antibodies against one or more donor HLA antigens

  • Patient has undergone prior autologous or allogeneic stem cell transplant.

  • Inability to collect sufficient peripheral blood stem cells from the donor

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Omission of the drug mycophenolate mofetil
Phase: 2
Study Start date:
April 26, 2022
Estimated Completion Date:
March 07, 2026

Connect with a study center

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

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