← Back to Search

Other

Stem Cell Transplant Without Mycophenolate Mofetil for Blood Cancer (OmitMMF Trial)

Phase 2
Waitlist Available
Led By Ronald Paquette, MD
Research Sponsored by Ronald Paquette
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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.
Must not have
Patient has a diagnosis of myelofibrosis
Inability to collect sufficient peripheral blood stem cells from the donor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year post-transplant and 2-years post-transplant
Awards & highlights

Summary

This trial is testing whether omitting MMF from the standard stem cell transplant treatment protocol is feasible, safe and potentially beneficial. 60 patients will be followed for up to 2 years to see what happens.

Who is the study for?
This trial is for patients aged 18-75 with blood cancers needing a stem cell transplant and approved by Cedars-Sinai's committee. They must be suitable for a specific chemo and radiation regimen, have not had previous transplants, and have an HLA-matched donor ready to donate stem cells.
What is being tested?
The study tests the safety of removing mycophenolate mofetil (MMF) from standard allogeneic stem cell transplant treatment in 60 patients. It aims to see if this change is feasible and beneficial over two years post-transplant without affecting graft-versus-host disease prevention.
What are the potential side effects?
Potential side effects may include increased risk of graft-versus-host disease due to less immune suppression without MMF, as well as typical risks associated with stem cell transplantation like infection or reaction to the new cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am considered fit for a specific transplant prep treatment with Fludarabine and radiation.
Select...
I have a donor who is a close genetic match for my transplant.
Select...
I am between 18 and 75 years old.
Select...
I am willing to donate my stem cells through a blood draw.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with myelofibrosis.
Select...
My donor couldn't provide enough stem cells through a blood draw.
Select...
I have high levels of antibodies against donor tissues.
Select...
I have had a stem cell transplant before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-transplant and 2 years post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-transplant and 2 years post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Engraftment failure
Secondary study objectives
Graft Versus Host Disease (GVHD)-free, Relapse Free Survival
Overall Survival (OS)
Rate of severe acute GVHD by day +100.
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open ArmExperimental Treatment1 Intervention
Omission of the drug mycophenolate mofetil

Find a Location

Who is running the clinical trial?

Ronald PaquetteLead Sponsor
1 Previous Clinical Trials
26 Total Patients Enrolled
Ronald Paquette, MDPrincipal InvestigatorCedars-Sinai Medical Center
5 Previous Clinical Trials
42 Total Patients Enrolled

Media Library

Omission of the drug mycophenolate mofetil (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05256537 — Phase 2
Blood Cancers Research Study Groups: Open Arm
Blood Cancers Clinical Trial 2023: Omission of the drug mycophenolate mofetil Highlights & Side Effects. Trial Name: NCT05256537 — Phase 2
Omission of the drug mycophenolate mofetil (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05256537 — Phase 2
~0 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top