← Back to Search

Other

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

Phase 2

Recruiting

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-year post-transplant and 2-years post-transplant

Awards & highlights

OmitMMF Trial 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.Check my eligibility

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.See study design

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.

OmitMMF Trial 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.

OmitMMF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post-transplant and 2 years post-transplant

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Engraftment failure

Secondary outcome measures

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

Overall Survival (OS)

Rate of severe acute GVHD by day +100.

+4 more

OmitMMF Trial Design

1Treatment groups

Experimental Treatment

Group I: Open ArmExperimental Treatment1 Intervention

Omission of the drug mycophenolate mofetil

0 / 4Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are joining this research endeavor?

"Affirmative. Clinicaltrials.gov has evidence that this clinical trial is actively admitting patients, which was posted on April 26th 2022 and recently modified on July 20th. The program requires 60 participants to be recruited at a single location."

Answered by AI

What criteria must potential participants meet to join this experiment?

"This trial is recruiting 60 subjects suffering from haematological neoplasms, aged between 18 and 75. Eligible patients must meet the following criteria: age of 18-75 years, an HLA haploidentical related donor or single antigen mismatch unrelated donor, signed informed consent form for study participation, a hematologic malignancy other than myelofibrosis which meets standard criteria for allogeneic stem cell transplant (separate clinical consent required), deemed suitable to receive Fludarabine/Total Body Irradiation 1125 or 800 conditioning regimens as standard of care transplant and a willing peripheral blood stem cells"

Answered by AI

Are there openings for enrolment in this experiment at present?

"Clinicaltrials.gov confirms that this clinical trial is still open for recruitment, with the initial post date of April 26th 2022 and most recent update on July 20th 2022."

Answered by AI

Does the trial encompass participants of all ages, or are there any age restrictions?

"According to the enrollment stipulations, prospective patients must have an age between 18 and 75. Meanwhile, there are 121 studies already conducted for minors and 369 clinical trials designed for individuals above 65 years of age."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Ronald Paquette 2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05256537.

All > Blood Cancer