Recruiting
Phase 2

Ruxolitinib & Transplantation

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06345495

Conditions

Splenomegaly

Myelofibrosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ruxolitinib

Allogeneic Stem Cell Transplantation

Levetiracetam

Eltrombopag

Busulfan

Study Details

Brief 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.

Conditions

Splenomegaly

Myelofibrosis

Study ID

NCT06345495

Start date

Oct 1, 2024

Status verified date

Aug, 2026

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Participants 18 years to less than or equal to 75 years.
2. Able to provide written consent.
3. Primary or secondary Myelofibrosis (may have received Jak inhibitors including ruxolitinib)
4. 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.
5. Has a fully matched (8/8:HLA A, B, C, DRB1) related or matched unrelated donor.
6. 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.
7. Adequate liver function, including:

1. ALT/AST </= 3 x ULN
2. Direct bilirubin </= 1mg/dL
3. No history of liver cirrhosis. No ascites.
8. 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.
9. 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:

1. 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.
2. 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.

Exclusion Criteria:

1. Positive beta HCG in females of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.
2. Ejection fraction <40%
3. Corrected DLCO < 50%
4. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:

1. Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
2. Active hepatitis B virus (HBV), hepatitis C (HCV), HIV or TB infection or requiring treatment for the same.
3. 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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ruxolitinib and Allogeneic Stem Cell Transplantation

Participants will be asked to receive study drugs and a stem cell transplant and attend study visits, at which various tests and procedures will be performed. Participants are expected to receive treatment for about 100 days, followed by a year of follow-up.

Interventions

Ruxolitinib

Given by PO

Allogeneic Stem Cell Transplantation

Given by Transplant

Levetiracetam

Given by PO

Eltrombopag

Given by PO

Busulfan

Given by IV

Romiplostim

Given by IV

Fludarabine phosphate

Given by IV

Cyclophosphamide

Given by IV

Mesna

Given by IV

Tacrolimus

Given by IV or PO

Primary outcome measure

  • Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts and Locations

Central contacts

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Uday Popat, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-20.