Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06345495

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

Led by M.D. Anderson Cancer Center · Updated on 2026-03-11

30

Participants Needed

1

Research Sites

221 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

I

Incyte Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

To learn if giving ruxolitinib and busulfan before a stem cell transplant can help to reduce spleen size and help the transplant to succeed.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years
  • Able to provide written consent
  • Diagnosis of primary or secondary myelofibrosis (may have received Jak inhibitors including ruxolitinib)
  • Enlarged spleen by palpation or imaging (palpable spleen or larger than 12 cm on imaging)
  • Fully matched (8/8 HLA A, B, C, DRB1) related or matched unrelated donor
  • Adequate kidney function (serum creatinine 4 1.5 mg/dL or eGFR E= 40 ml/min/1.73 m2)
  • Adequate liver function (ALT/AST 4 times upper limit of normal, direct bilirubin 4 1 mg/dL)
  • No history of liver cirrhosis or ascites
  • Female participants of childbearing potential must have a negative serum pregnancy test and agree not to breastfeed during the study and for 3 months after
  • Participants of childbearing potential must agree to use highly effective contraception during treatment and for 3 months afterward
Not Eligible

You will not qualify if you...

  • Positive pregnancy test in females of childbearing potential or lactating females
  • Ejection fraction less than 40%
  • Corrected DLCO less than 50%
  • Uncontrolled or active systemic infections (viral, bacterial, or fungal)
  • Active hepatitis B, hepatitis C, HIV, or tuberculosis infection or currently treated for these
  • Thrombosis events (myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis) within the past 6 months
  • History of liver cirrhosis or ascites

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

U

Uday Popat, MD

CONTACT

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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