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

Hematologic Neoplasms Clinical Trial

— OmitMMF  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05256537
• Other study ID #: IIT2021-11-PAQUETTE-OmitMMF
• Status: Recruiting
• Phase: Phase 2
• Start date: April 26, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2023
• Source: Cedars-Sinai Medical Center
• Contact: Amy Oppenheim
• Phone: 310-423-3713
• Email: Amy.Oppenheim[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Graft vs Host Disease
• Hematologic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Ronald Paquette

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engraftment failure	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.	60 days post-transplant
Secondary	Time to neutrophil and platelet engraftment	Days to neutrophil and platelet engraftment since transplant.	60 days post-transplant
Secondary	Rate of severe acute GVHD by day +100.	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.	100 days post-transplant
Secondary	Treatment-related mortality	Rate of treatment-related mortality	5 days post- transplant to 2-years
Secondary	Rate of severe chronic GVHD at 1 year	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.	1-year post-transplant
Secondary	Relapse	Relapse rate at 1 and 2 years	1 year post-transplant and 2 years post-transplant
Secondary	Overall Survival (OS)	Overall survival at 1 and 2 years	1-year post-transplant and 2-years post-transplant
Secondary	Graft Versus Host Disease (GVHD)-free, Relapse Free Survival	Rate of GVHD-free, Relapse Free Survival	1-year post- transplant and 2-years post-transplant