Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell Transplant
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This phase I trial tests the safety, side effects and effectiveness of emapalumab with post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil in preventing graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after reduced-intensity donor (allogeneic) hematopoietic cell transplant (HCT). Giving chemotherapy, such as fludarabine, melphalan, or busulfan, before a donor \[peripheral blood stem cell\] transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When healthy stem cells for a donor are infused into a patient (allogeneic HCT), they may help the patient's bone marrow make more healthy cells and platelets. Allogeneic HCT is an established treatment, however, GVHD continues to be a major problem of allogeneic HCT that can complicate therapy. GVHD is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Emapalumab binds to an immune system protein called interferon gamma. This may help lower the body's immune response and reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants. Mycophenolate mofetil is a drug used to prevent GVHD after organ transplants. It is also being studied in the prevention of GVHD after stem cell transplants for cancer, and in the treatment of some autoimmune disorders. Mycophenolate mofetil is a type of immunosuppressive agent. Giving emapalumab with post-transplant cyclophosphamide, tacrolimus and mycophenolate mofetil may be safe, tolerable and/or effective in preventing GVHD in patients with AML or MDS after a reduced-intensity allogeneic HCT.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Zgoda uczestnika lub jego przedstawiciela prawnego na udział w badaniu.
- •Pacjent ma od 18 do 75 lat. Pacjenci powyżej 70 lat muszą mieć dobry ogólny stan zdrowia i niski wskaźnik chorób współistniejących.
- •Pacjent ma ostry białaczkę szpikową (AML) lub zespoły mielodysplastyczne (MDS) w remisji, bez obecności komórek nowotworowych w szpiku kostnym.
- •Pacjent ma przejść przeszczep komórek macierzystych od zgodnego dawcy (pokrewnego lub niespokrewnionego) po przygotowaniu chemioterapią.
- •Wyniki badań krwi i czynności serca są w normie.
✗ Disqualifies
- •W przypadku niektórych chorób wątroby, nerek lub serca pacjent może nie zostać zakwalifikowany.
- •W przypadku chorób płuc lub jeśli pacjent nie jest w stanie wykonać testów płucnych, jego stan jest oceniany indywidualnie.
- •Pacjent nie może mieć aktywnego zakażenia wirusem HIV, zapalenia wątroby typu C lub B, chyba że ilość wirusa jest niewykrywalna.
- •Niektóre inne choroby lub przyjmowane leki mogą uniemożliwić udział w badaniu.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- July 1, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
City of Hope Medical Center
Duarte, United States
Trial contact
Amandeep Salhotra
Amandeep Salhotra
PRINCIPAL_INVESTIGATOR
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.