Actively Recruiting
Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation After Reduced Intensity Conditioning
Led by City of Hope Medical Center · Updated on 2025-06-27
35
Participants Needed
1
Research Sites
182 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 II trial studies how well vedolizumab plus post-transplant cyclophosphamide (PTCy) and short course tacrolimus work for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) after reduced intensity conditioning. Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a donor. Giving reduced conditioning chemotherapy before an allogeneic HCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new stem cells to grow using less than standard doses of chemotherapy. Sometimes, the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Vedolizumab is a monoclonal antibody, which is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). It may 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 suppresses the immune system by preventing the activation of certain types of immune cells. Giving vedolizumab plus PTCy and short course tacrolimus may be effective at preventing GVHD after allogeneic HCT.
CONDITIONS
Official Title
Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation After Reduced Intensity Conditioning
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide documented informed consent and assent if appropriate
- Allow use of archival tumor biopsy tissue or obtain approval for exception
- Be aged 18 to 80 years
- If older than 70, have Karnofsky performance status of at least 80 and hematopoietic cell transplantation-comorbidity index of 2 or less
- Have Karnofsky performance status of at least 70%
- Diagnosed with acute myeloid or lymphoblastic leukemia in remission with less than 5% bone marrow blasts, myelodysplastic syndrome with less than 10% blasts, myeloproliferative neoplasm other than myelofibrosis needing transplant, or chronic myelomonocytic leukemia
- Have hemoglobin level of at least 9 g/dL within 30 days before starting treatment
- Have total bilirubin of 2.0 mg/dL or less unless Gilbert's disease, and liver enzymes under specified limits within 30 days before treatment
- Have creatinine clearance of 1.5 mg/dL or less or at least 60 mL/min per 24 hour urine test or Cockcroft-Gault formula within 30 days before treatment
- Have left ventricular ejection fraction of at least 50% within 28 days before treatment
- If able, have pulmonary function tests (FEV1, FVC, DLCO) at least 50% of predicted within 28 days before treatment
- If unable to perform pulmonary tests, have oxygen saturation over 92% on room air within 28 days before treatment
- Be seronegative for HIV, hepatitis C, and active hepatitis B within 30 days before treatment, or HIV-positive on effective therapy with undetectable viral load within 6 months
- Have negative tuberculosis test or have follow-up and treatment if positive
- Meet institutional and federal infectious disease testing requirements within 28 days before treatment
- Women of childbearing potential must have negative pregnancy test within 30 days before treatment
- Agree to use effective birth control or abstain from heterosexual activity during study and for 3 months after last treatment dose
You will not qualify if you...
- Have had a prior allogeneic hematopoietic cell transplant
- Received chemotherapy, radiation, biological therapy, or immunotherapy within 14 days before treatment (except conditioning regimen)
- Taken other investigational drugs for GVHD prevention
- Using herbal medications
- Have history of allergic reactions to similar compounds as study drugs
- Have serious uncontrolled illness
- Have active infection not responding to antibiotics
- Have other active cancer that may interfere with study safety or efficacy
- Are pregnant or breastfeeding (females only)
- Are unlikely to be available for follow-up at the study institution for at least 100 days post-transplant
- Have any condition that makes participation unsafe or prevents compliance with study procedures as judged by the investigator
AI-Screening
AI-Powered 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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