RecruitingPhase 2

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

United States30 participantsStarted 2024-10-01

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. Adequate liver function, including:
✓. ALT/AST \</= 3 x ULN

✕. 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

Safety and adverse events (AEs)

Timeframe: Through study completion; an average of 1 year.

NCT IDNCT06345495

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-01

Uday Popat, MD

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. Adequate liver function, including:
✓. ALT/AST \</= 3 x ULN

✕. 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