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Study identifier: NCT05436418 Synced from ClinicalTrials.gov · July 29, 2026
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The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation

Condition: Peripheral Blood Stem Cell Transplantation · Hematopoietic Stem Cell Transplantation  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 1/Phase 2
Planned participants260
Who can joinAll sexes, 12 Years to 120 Years
Healthy volunteersYes

About this study

Background: Blood cancers (such as leukemias or lymphomas) often do not respond to standard treatments. A transplant of blood stem cells from a healthy donor can help people with these cancers. Sometimes these transplants cause serious side effects, including a common immunologic problem called graft-versus-host disease. A drug called cyclophosphamide given early after the transplant (post-transplantation cyclophosphamide, PTCy) can reduce these complications. But sometimes this drug has its own negative effects. Furthermore, studies in mice suggest that an intermediate, rather than very high, dose of this drug may best protect against graft-versus-host disease. Objective: To find out if a lower dose of PTCy is more helpful for people who undergo blood stem cell transplants. Eligibility: People aged 18 and older who have a blood cancer and are eligible for a transplant of blood stem cells from another person. Healthy donors are also needed but must be related to the individual needing the transplant. Design: Participants will undergo screening. Transplant recipients will have imaging scans and tests of their heart and lung function. They will be assessed for the status of their cancer, including bone marrow taken from their pelvis and possibly also scans and/or fluid drawn from the spine depending on the disease type. Donors will be screened for general health. They will give several tubes of blood. They will give an oral swab and saliva and stool samples for research…

This description comes directly from the study's public registry record.

Talk to the study team

Amy H Chai  ·  (240) 858-3755  ·  amy.chai@nih.gov

Christopher G Kanakry, M.D.  ·  (240) 760-6171  ·  christopher.kanakry@nih.gov

Always discuss trial participation with your own doctor first.

Locations (2)

City of HopeDuarte, California, United StatesNot Yet Recruiting
National Institutes of Health Clinical CenterBethesda, Maryland, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05436418