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NCT06752694

Ruxolitinib Based GVHD Prophylaxis Regimen Before, During, and After Hematopoietic Cell Transplantation in Older Adult Patients With Acquired Aplastic Anemia

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Fred Hutchinson Cancer Center
~1 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone Marrow AspirationBone Marrow BiopsyBone Marrow TransplantationComputed TomographyCyclosporine

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of grades II-IV acute graft-versus-host disease (GVHD)
Measured over At day 100

Conditions

Aplastic Anemia

Explore related trials

Aplastic Anemia

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Rachel B. Salit, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age \> 40 years or ages 18 - 40 years with Hematopoietic Cell Transplantation - Specific Comorbidity Index (HCT-CI) score \> 3 necessitating a low intensity transplant or determined inability to tolerate antithymocyte globulin (ATG)
Diagnosis of severe acquired aplastic anemia defined as a bone marrow hypoplasia (\< 25% or 25-50% with \< 30% residual hematopoietic cells) shown by a biopsy and at least two of the three following criteria: absolute neutrophil count (ANC) \< 0.5×10\^9/L, platelets \< 20×10\^9/L, or absolute reticulocytes \< 40×10\^9/L or
Non-severe acquired aplastic anemia defined as a hypocellular marrow and transfusion dependent (red cells and/or platelets)
Does not meet World Health Organization (WHO) criteria for myelodysplastic syndrome (MDS)
Ability to understand and the willingness to sign a written informed consent document
Patient must be a potential hematopoietic stem cell transplant candidate as assessed by the consenting physician
Karnofsky ≥ 70
Calculated creatinine clearance using the Cockcroft-Gault formula or 24 hr urine creatinine clearance must be \> 60 ml/min
Total serum bilirubin must be \< 2 mg/dL unless the elevation is thought to be due to Gilbert's disease or hemolysis
Transaminases must be \< 3x the upper limit of normal
Patients with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension. Patients with fulminant liver failure, cirrhosis with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis, hepatic encephalopathy, or correctable hepatic synthetic dysfunction evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin \> 3mg/dL, and symptomatic biliary disease will be excluded
Diffusing capacity for carbon monoxide (DLCO) corrected \> 60% normal
May not be on supplemental oxygen
Left ventricular ejection fraction \> 40% OR shortening fraction \> 26%
Patients may have received prior treatment for their AA but they are NOT required to have received immune suppression prior to consideration for transplant

Exclusion

Contraindication to receiving ruxolitinib including: patients who have known hypersensitivity to JAK inhibitors and excipients
Patients with history of myocardial infarction (MI), cerebrovascular accident (CVA) or unprovoked pulmonary embolism (PE)/deep vein thrombosis (DVT) in past 6 months
History of prior allogeneic transplant
Active or recent infection without infectious disease (ID) consult and approval
History of untreated tuberculosis (TB)
History of HIV infection
Pregnant or breastfeeding
History of prior malignancy with \> 20% risk of recurrence in the next 5 years
Patients without an HLA-identical sibling donor, 10 of 10 HLA-matched or 9 of 10 mismatched unrelated donor that meet transplant criteria

What this trial measures

  • Incidence of grades II-IV acute graft-versus-host disease (GVHD)At day 100

    Will be estimated as simple proportions and informally compared to the historical controls at Fred Hutch. (i.e., estimates presented descriptively, but no formal statistical comparisons will be made).