Fludarabine and Total Body Irradiation 800 Centigray (cGy) or 1125 cGy For Allogeneic Stem Cell T… (NCT05256537) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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
United States60 participantsStarted 2022-04-26
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing two different radiation doses — 800 cGy and 1125 cGy — as part of the conditioning regimen before transplant, so can you explain what the difference in radiation dose might mean for my risks and recovery, and which dose I would likely receive?
2The trial is specifically measuring engraftment failure as its primary outcome, meaning whether the donor cells successfully take hold — how does the risk of engraftment failure in this study compare to what I might expect with a standard transplant approach?
3This trial uses post-transplant cyclophosphamide and tacrolimus for graft-versus-host disease prevention, but leaves out mycophenolate mofetil, which is sometimes part of standard regimens — can you explain why that drug was removed and what that might mean for my risk of developing graft-versus-host disease?
4Since this is a Phase 2 trial that is no longer actively enrolling new participants, does that affect my options, and is there a related or follow-up study I might still be eligible for, or would standard-of-care transplant be the better path for me right now?
5Given that this trial involves both chemotherapy with fludarabine and high-dose total body irradiation, how does the intensity of this conditioning regimen fit my current health status, and what side effects should I realistically prepare for?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.