Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell Transplant

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06996119
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Busulfan — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo chest CT
  • Cyclophosphamide — DRUG
    Given IV
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Emapalumab — BIOLOGICAL
    Given IV
  • Fludarabine — DRUG
    Given IV
  • Hematopoietic Cell Transplantation — PROCEDURE
    Given infusion
  • Melphalan — DRUG
    Given IV
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Mycophenolate Mofetil — DRUG
    Given IV or PO
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Tacrolimus — DRUG
    Given IV or PO

Study Details

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.

Key Dates

Start date
May 25, 2026
Status verified
May 2026
Primary completion
May 25, 2027
Completion
May 25, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Prevention (emapalumab, cyclophosphamide)
    Patients receive fludarabine IV on days -7 to -3 and melphalan IV over 1 hour on day -2 or busulfan IV on days -7 and -6 and fludarabine IV on days -7 to -2. Patients receive HCT infusion on day 0 per institutional standards of practice. Patients also receive emapalumab IV over 1 hour on days -8. -1, -7, 14 and 21, cyclophosphamide IV on days 3 and 4, tacrolimus IV or PO on days 5-95, mycophenolate mofetil IV or PO on days 5-35. Additionally, patients undergo chest CT and ECHO or MUGA at baseline and blood sample collection throughout the study.

Primary Outcome Measure

Incidence of grade 3 or higher adverse events (AEs) [ Time Frame: From starting the first emapalumab dose to the first observation of a primary safety endpoint (PSE) event or day 28 post-hematopoietic cell transplantation (HCT), whichever comes first ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Amandeep Salhotra
[email protected]
626-218-2405
Amandeep Salhotra (PRINCIPAL_INVESTIGATOR)

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City of Hope Medical Center· Duarte, CA

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