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December 8, 2025BloodOpen Access

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 (OmitMMF trial)

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Authors

RPRonald PaquetteCedars-Sinai Medical CenterVCVinícius F. CalsavaraCedars-Sinai Medical Center

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Implication

Open label trial shows safe omission of mycophenolate mofetil in transplant patients, indicating similar GVHD rates with tacrolimus.

Key Points

  • To evaluate the safety and benefits of omitting mycophenolate mofetil during allogeneic stem cell transplants with specific conditioning regimens.
  • Open label phase 2 study
  • Evaluated 60 patients with RI and MA conditioning
  • Compared outcomes to matched historical control patients
  • Analyzed rates of acute GVHD, graft rejection, and survival
  • Monitored viral reactivation rates.
  • No significant difference in neutrophil engraftment times (p = 0.31)
  • Low rate of grade III-IV acute GVHD in both groups (0% vs 1.7%, p = 0.31)
  • Graft rejection occurred in one OmitMMF patient due to poor graft viability
  • One year overall survival similar in both groups (97% vs 93%, p = 0.41)
  • Grade II-IV acute GVHD was higher in OmitMMF patients receiving myeloablative conditioning (p = 0.024).

Cite This Study

Paquette et al. (2025) studied this question.

synapsesocial.com/papers/69362f634fa91c937236ddf5https://doi.org/10.1182/blood-2025-4244
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. Diagnosis and Staging Working Group Report2005 · 3,579 citations
  2. 2Regression Models and Life-Tables1972 · 39,968 citations
  3. 3HLA-Haploidentical Bone Marrow Transplantation for Hematologic Malignancies Using Nonmyeloablative Conditioning and High-Dose, Posttransplantation Cyclophosphamide2008 · 1,964 citations
  4. 4Fludarabine and Total-Body Irradiation Conditioning before Ablative Haploidentical Transplantation: Long-Term Safety and Efficacy2019 · 26 citations
  5. 5Total Body Irradiation–Based Myeloablative Haploidentical Stem Cell Transplantation Is a Safe and Effective Alternative to Unrelated Donor Transplantation in Patients Without Matched Sibling Donors2015 · 159 citations