Ruxolitinib for Preventing Graft Versus Host Disease in Pediatric and Young Adult Leukemia Patients
This study is testing if adding ruxolitinib to standard medications (tacrolimus and methotrexate) can help prevent graft versus host disease (GVHD) in children and young adults (ages 2-22) who are receiving a stem cell transplant for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Ruxolitinib works by blocking signals that cause inflammation and cell growth, which may help prevent GVHD. Tacrolimus also helps prevent the body from rejecting the transplant by calming the immune system. The study aims to see how safe this combination is and how well it prevents GVHD and relapse one year after transplant. About 40 patients are expected to join this study.
- Study design
- This is an interventional study that will enroll about 40 participants. It will first assess safety and then evaluate how well the treatment works.
- What's involved
- You would undergo blood sample collection, chest CT scans, echocardiograms (ECHO), and hematopoietic cell transplantation (HCT). Methotrexate will be given intravenously.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure adverse events up to 30 days after transplant and assess GVHD-free and relapse-free survival at 1 year post-transplantation.
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NCT06128070
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
Recruiting
PHASE2Ages 2–22InterventionalPreventionCity of Hope Medical CenterInvestigator-initiated
~40 participants
Updated 2025-10-31 on ClinicalTrials.gov
What's tested:Biospecimen CollectionChest Computed TomographyEchocardiographyHematopoietic Cell TransplantationMethotrexateMultigated Acquisition Scan
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to day +30 post hematopoietic cell transplant (HCT)
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Haris Ali · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study primary investigator (PI) approval
Age: 2-22
Weight ≥25kg
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Performance status: Karnofsky ≥ 60% for patients ≥ 16 years old OR Lansky status ≥ 60% for patients \< 16 years old
Candidate for allogeneic bone marrow transplant with and available matched related donor (MRD) or an 8/8 matched unrelated donor (MUD) who is willing to donate bone marrow (BM) or mobilized peripheral blood stem cells
Note: Donor selection process will be in accordance with City of Hope (COH)-standard operating procedures (SOPs) (B.001.09 Allogeneic Cellular Therapy Product Donor Evaluation, Selection \& Consent), which follows Food and Drug Administration (FDA) guidelines for donation of hematopoietic stem/progenitor cells (HPCs) obtained from peripheral blood or bone marrow
Diagnosis of acute leukemia (acute myeloid leukemia \[AML\] or acute lymphoblastic leukemia \[ALL\]) in complete remission, or myelodysplastic syndrome (MDS)
Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 from prior anti-cancer therapy
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (to be performed within 30 days prior to day 1 of protocol therapy)
Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
Exclusion
Autologous stem cell transplant within 1 year prior to day 1 of protocol therapy
Prior allogeneic transplantation
Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy
Note: Conditioning regimen within 21 days prior to day 1 of protocol therapy is not considered as an exclusion criterion.
Note: Patients on maintenance chemotherapy with agents listed are not excluded
Herbal medications
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
History of active tuberculosis
Patients with history of thrombosis including but not limited to myocardial infarction (MI)/stroke and pulmonary embolism (PE)/deep vein thrombosis (DVT) within 6 months of enrollment
Active diarrhea due to inflammatory bowel disease or malabsorption syndrome
Clinically significant uncontrolled illness
Active, uncontrolled systemic infection (viral, bacterial, or fungal) requiring antibiotics
Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection
Other active malignancy
Females only: Pregnant or breastfeeding
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
What this trial measures
- Incidence of adverse eventsUp to day +30 post hematopoietic cell transplant (HCT)
Defined using the modified Bearman Scale and the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 scale.
- Graft-versus-host disease (GVHD)-free and relapse-free (GRFS)From the date of transplantation to the first time of observing the following events: grade 3-4 acute GVHD, chronic GVHD requiring systemic treatment, relapse, or death, assessed at 1 year post transplantation
Will be estimated using the product-limit method of Kaplan and Meier.