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

Recruiting in Palo Alto (17 mi)

Overseen byRonald Paquette, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Ronald Paquette

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ronald Paquette, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I am considered fit for a specific transplant prep treatment with Fludarabine and radiation.

I am approved for a stem cell transplant for my blood cancer, not including myelofibrosis.

I have a donor who is a close genetic match for my transplant.

See 3 more

Exclusion Criteria

I have been diagnosed with myelofibrosis.

My donor couldn't provide enough stem cells through a blood draw.

I have high levels of antibodies against donor tissues.

See 1 more

Treatment Details

Interventions

Omission of the drug mycophenolate mofetil (Other)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Open ArmExperimental Treatment1 Intervention

Omission of the drug mycophenolate mofetil