High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to 75 Years
• SexAll
• Healthy volunteersNo

You may be able to join if

• Participants 18 years to less than or equal to 75 years.
• Able to provide written consent.
• Primary or secondary Myelofibrosis (may have received Jak inhibitors including ruxolitinib)
• Enlarged spleen by palpation or imaging. For the purpose of this study, splenomegaly is defined as any clinically palpable spleen or spleen larger than 12 cms on imaging.
• Has a fully matched (8/8:HLA A, B, C, DRB1) related or matched unrelated donor.
• Adequate renal function, including:
• a. Serum creatinine </= 1.5 mg/dL or estimated Glomerular Filtration Rate (eGFR using the CKI-EPI equation) >/= 40 ml/min/1.73 m2.
• Adequate liver function, including:
• ALT/AST </= 3 x ULN
• Direct bilirubin </= 1mg/dL
• No history of liver cirrhosis. No ascites.
• Female participants of childbearing potential must have negative results for a serum pregnancy test. Female participants must agree to not breastfeed during the study and for 3 months post-completion of the study therapy.
• Subjects who are of childbearing potential, sexually active, and at risk of pregnancy must agree to use a highly effective method of contraception for the duration of the active treatment and at least 3 months post-completion of the study therapy. Highly effective methods of contraception include the following:
• Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study agent administration. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.

You cannot join if

• Positive beta HCG in females of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.
• Ejection fraction <40%
• Corrected DLCO < 50%
• Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
• Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
• Active hepatitis B virus (HBV), hepatitis C (HCV), HIV or TB infection or requiring treatment for the same.
• Thrombosis including MI, Stroke, PE, DVT in the past 6 months
• Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

ruxolitinib phosphate. The phosphate salt form of ruxolitinib, an orally bioavailable Janus-associated kinase (JAK) inhibitor with potential antineoplastic and immunomodulating activities. Ruxolitinib specifically binds to and inhibits protein tyrosine kinases JAK 1 and 2, which may lead to a reduction in inflammation and an inhibition of cellular proliferation. The JAK-STAT (signal transducer and activator of transcription) pathway plays a key role in the signaling of many cytokines and growth factors and is involved in cellular proliferation, growth, hematopoiesis, and the immune response; JAK kinases may be upregulated in inflammatory diseases, myeloproliferative disorders, and various malignancies. NCI Drug Dictionary

Treatments listed in the registry

• Ruxolitinib (Drug): Given by PO
• Allogeneic Stem Cell Transplantation (Procedure): Given by Transplant
• Levetiracetam (Drug): Given by PO
• Eltrombopag (Drug): Given by PO
• Busulfan (Drug): Given by IV
• Romiplostim (Drug): Given by IV
• Fludarabine phosphate (Drug): Given by IV
• Cyclophosphamide (Drug): Given by IV
• Mesna (Drug): Given by IV
• Tacrolimus (Drug): Given by IV or PO

Na · Single Group · masking: None

Main goals

• Safety and adverse events (AEs) (Through study completion; an average of 1 year.)

Planned enrollment: 30 (estimated).

• MD Anderson Cancer Center, Houston, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06345495
• NCI Drug Dictionary: C97937

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 15, 2026. Public record; not medical advice.