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NCT Number: NCT05256537

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hematologic Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 standard criteria 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 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

Treatment and study plan

Omission of the drug mycophenolate mofetil

Other

Elimination of the immunosuppressive drug mycophenolate mofetil (MMF) from the post-transplant regimen.

Primary outcomes

  1. Engraftment failure

    Time frame: 60 days post-transplant

    Evaluate the feasibility of eliminating the drug Mycophenolate Mofetil (MMF) from the transplant regimens as determined by an acceptable rate of engraftment failure (<10%). Engraftment failure is when the blood-forming cells received on transplant day do not start to grow and make healthy blood cells.

Secondary outcomes

  1. Time to neutrophil and platelet engraftment

    Time frame: 60 days post-transplant

    Days to neutrophil and platelet engraftment since transplant.

  2. Rate of severe acute GVHD by day +100.

    Time frame: 100 days post-transplant

    Proportion of patients with severe acute GVHD at day 100 post-transplantation.

    • Acute GVHD is when the donated stem cells attack the body within the first 100 days post-transplant.
    • The modified Keystone criteria will be used for acute GVHD staging and grading.

  3. Treatment-related mortality

    Time frame: 5 days post- transplant to 2-years

    Rate of treatment-related mortality

  4. Rate of severe chronic GVHD at 1 year

    Time frame: 1-year post-transplant

    Proportion of patients with severe chronic GVHD at day 365 post-transplantation.

    -Chronic GVHD is when the donated stem cells attack the body after 100 days post-transplant. Chronic GVHD is defined by NIH Consensus Criteria for chronic GVHD.

  5. Relapse

    Time frame: 1 year post-transplant and 2 years post-transplant

    Relapse rate at 1 and 2 years

  6. Overall Survival (OS)

    Time frame: 1-year post-transplant and 2-years post-transplant

    Overall survival at 1 and 2 years

  7. Graft Versus Host Disease (GVHD)-free, Relapse Free Survival

    Time frame: 1-year post- transplant and 2-years post-transplant

    Rate of GVHD-free, Relapse Free Survival

Sponsors and collaborators

Lead sponsor

Ronald Paquette

Other

Registry information

Official study title

IIT2021-11-PAQUETTE-OmitMMF: Fludarabine and Total Body Irradiation 800 cGy or 1125 cGy For Allogeneic Stem Cell Transplant Using Graft Versus Host Disease Prophylaxis With Post-Transplant Cyclophosphamide and Tacrolimus, Without Mycophenolate Mofetil

Acronym: OmitMMF

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Feb 25, 2022
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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