Actively Recruiting
Ruxolitinib With Tacrolimus and Methotrexate for the Prevention of Graft Versus Host Disease in Pediatric and Young Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome
Led by City of Hope Medical Center · Updated on 2025-10-31
40
Participants Needed
1
Research Sites
331 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 tests how well ruxolitinib with tacrolimus and methotrexate work to prevent the development of graft versus host disease in pediatric and young adult patients undergoing allogeneic hematopoietic cell transplant for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Ruxolitinib is a type of medication called a kinase inhibitor. It works by blocking the signals of cells that cause inflammation and cell proliferation, which may help prevent graft versus host disease (GVHD). Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants by suppressing the immune system. Methotrexate stops cells from making DNA, may kill cancer cells, and also suppress the immune system, which may reduce the risk of GVHD. Giving ruxolitinib with tacrolimus and methotrexate may prevent GVHD in pediatric and young adults undergoing allogeneic hematopoietic cell transplants.
CONDITIONS
Official Title
Ruxolitinib With Tacrolimus and Methotrexate for the Prevention of Graft Versus Host Disease in Pediatric and Young Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and assent when appropriate
- Agreement to allow use of diagnostic tumor biopsy tissue or approval for exception
- Age between 2 and 22 years
- Weight of at least 25 kg
- ECOG performance status of 0, 1, or 2
- Karnofsky score ≥ 60% if age 16 or older, or Lansky score ≥ 60% if younger than 16
- Candidate for allogeneic bone marrow transplant with matched related or 8/8 matched unrelated donor willing to donate bone marrow or stem cells
- Diagnosis of acute myeloid leukemia or acute lymphoblastic leukemia in complete remission, or myelodysplastic syndrome
- Fully recovered from prior anti-cancer therapy toxic effects except alopecia, to grade 1 or less
- Negative pregnancy test if of childbearing potential
- Agreement to use birth control or abstain from heterosexual activity during and 6 months after treatment if of childbearing potential
You will not qualify if you...
- Autologous stem cell transplant within 1 year prior to treatment
- Prior allogeneic transplantation
- Chemotherapy, radiation, biological therapy, or immunotherapy within 14 days before treatment (except conditioning regimen within 21 days and certain maintenance chemotherapy)
- Use of herbal medications
- Allergic reactions to similar drugs
- History of active tuberculosis
- History of thrombosis (heart attack, stroke, pulmonary embolism, deep vein thrombosis) within 6 months
- Active diarrhea from inflammatory bowel disease or malabsorption syndrome
- Clinically significant uncontrolled illness
- Active uncontrolled infection requiring antibiotics
- Known HIV, hepatitis B, or hepatitis C infection
- Other active cancer
- Pregnant or breastfeeding females
- Any condition that contraindicates participation for safety reasons
- Inability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
PREVENTION
Number of Arms
1
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