Actively Recruiting
Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell Transplant
Led by City of Hope Medical Center · Updated on 2026-05-11
15
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent and assent as appropriate per institutional guidelines
- Aged 18 to 75 years; patients over 70 must have Karnofsky performance status ≥ 80% and HCT-comorbidity index ≤ 2
- Karnofsky performance status ≥ 70%
- Diagnosed with AML or MDS in complete remission with bone marrow blasts < 5%; AML must be minimal residual disease negative
- Planned reduced-intensity conditioning with fludarabine/melphalan or busulfan/fludarabine prior to allogeneic HCT from an 8/8 matched related or unrelated donor
- Total bilirubin ≤ 1.5 times upper limit of normal unless Gilbert's disease
- AST and ALT ≤ 3 times upper limit of normal
- Creatinine clearance ≥ 60 mL/min (by 24-hour urine or Cockcroft-Gault formula)
- Left ventricular ejection fraction ≥ 50% within 30 days prior to therapy
- QTcB ≤ 480 ms
- Pulmonary function tests (FEV1, FVC, DLCO) ≥ 50% predicted if able; otherwise oxygen saturation > 92% on room air
- Seronegative for HIV, hepatitis C, and active hepatitis B, or undetectable viral load if positive
- Meets institutional infectious disease titer requirements with tuberculosis prophylaxis if at risk
- Women of childbearing potential must have negative pregnancy test and agree to use effective birth control or abstain through 180 days post-HCT
- Males of childbearing potential agree to use effective birth control or abstain through 180 days post-HCT
You will not qualify if you...
- Prior allogeneic hematopoietic cell transplantation
- Other cancer therapies within two weeks before HCT conditioning, except certain targeted agents up to one day before conditioning
- History of allergic reactions to similar compounds as study agents
- Psychological issues, lack of appropriate caregivers, or medication non-compliance
- Clinically significant uncontrolled illness
- Active uncontrolled infections
- Other active malignancies
- Pregnant or breastfeeding women
- Any condition judged by investigators to contraindicate study participation
- Inability or unwillingness to comply with study procedures including feasibility or logistics issues
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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