New drug combo aims to make bone marrow transplants safer for rare blood cancer
NCT ID NCT07104799
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests the safety and best dose of the drug momelotinib when given before, during, and after a stem cell transplant for people with myelofibrosis, a serious bone marrow disorder. About 28 participants will receive momelotinib pills daily for up to 13 cycles. The goal is to find a dose that limits side effects while supporting transplant recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Momelotinib (a drug taken orally once daily)
- What this could lead to
- If successful, this could point toward a safer way to use momelotinib alongside stem cell transplants for myelofibrosis, potentially improving outcomes.
- What could go wrong
- This is a very early (Phase 1) and small (28 people) trial focused on safety and dosing, not yet on effectiveness. It may not lead to a new standard treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2026
- Expected to finish
-
Jan 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants must have pathologically confirmed primary myelofibrosis (PMF) according to WHO criteria or secondary myelofibrosis as defined by the IWG-MRT criteria. * Intermediate-2/ high-risk disease as per Dynamic IPSS (DIPSS) Plus criteria OR * Intermediate-1 risk disease with at least one of the following unfavorable features known to impact the survival adversely * Red cell transfusion dependency * Unfavorable Karyotype * Platelet count ≤100 x 10\^9/L * Presence of a high risk molecular marker associated with worsened overall survival (ASXL1, EZH2, IDH1/2, SRSF2, U2AF1, p53) * Participants do not have to be receiving treatment with JAK inhibitors for MF at the time of enrollment. If participants are receiving JAK inhibitor therapy with agents other momelotinib, participants must agree to be switched to momelotinib to begin Cycle 1 Day 1 on Day -7 from HCT (at the initiation of conditioning). * Age \>18 years * Participants must be designated to undergo allogeneic HCT with: * reduced intensity conditioning regimen, and * peripheral blood stem cells as a graft source * Participants who will undergo HCT from the following donor types are eligible: * 6/6 (HLA-A, B, DR) fully matched related donor or * 8/8 (HLA-A, B, DR, C) fully matched unrelated donor. Matching in the unrelated setting must be at the allele level * ECOG performance status ≤2 (Karnofsky ≥60%) * The effects of momelotinib on the developing human fetus are unknown. Female patients of childbearing potential must have a negative pregnancy test, as measured by serum or urine testing. Women of childbearing potential: must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 1 week after the last dose of momelotinib. Male participants with women of child bearing potential partners must agree to use one of the forms of medically acceptable birth control at start of the first treatment, during the study, and for at least 6 months after the last dose. See Exclusion Criteria for effective contraception and birth control. \- Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Known intolerance or hypersensitivity to any JAK inhibitor, including ruxolitinib, fedratinib, pacritinib, momelotinib or any other JAK inhibitor, its metabolites or formulation excipients. * Has had any major surgery within 28 days prior to randomization * Has received treatment with an investigational agent within 4 weeks of the first dose of study intervention * Has received immunosuppressive agents within 28 days * Prior allogeneic transplant for any hematopoietic disorder * Had accelerated phase or leukemic transformation (≥10% blasts in bone marrow any time prior to HCT) * Has an active, uncontrolled infection * Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice. * Known diagnosis of active hepatitis B or hepatitis C. * History of another malignancy(ies), unless: * the participant has been disease-free for at least 2 years and is deemed by the investigator to be at low risk of recurrence of that malignancy, or * the cancer has been deemed indolent with no progression over the last 2 years, and deemed by the investigator to be at low risk for further progression during the course of study and follow-up * the only prior malignancy was cervical cancer in situ and/or basal cell or squamous cell carcinoma of the skin * Participants without normal organ function defined as follows: * AST (SGOT), ALT (SGPT) and Alkaline Phosphatase \>3 × institutional Upper Limit of Normal (ULN) * Total bilirubin \>1.5 mg/dL, with the exception of participants with Gilbert's Syndrome provided direct bilirubin is ≤1.5x ULN and participant otherwise meets entry criteria. * Calculated creatinine clearance ≤60 mL/min (Cockcroft-Gault formula) * Have current or a history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (LVEF \< 40%, as measured by MUGA scan or echocardiogram) or clinically significant arrhythmia not controlled by standard of care therapy. * Not able to take oral medication or having any clinically significant gastrointestinal abnormalities that may alter absorption, e.g., malabsorption syndrome or major resection of the stomach and/or bowels. * Grade 2 or greater peripheral neuropathy * Pregnant or lactating women, or women planning to become pregnant or initiating breastfeeding. * To exclude women of childbearing potential: who are unwilling or unable to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 1 week after the last dose. Highly effective contraceptive measures include: * stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening; * intrauterine device (IUD); intrauterine hormone-releasing system (IUS); * sexual abstinence; * intercourse with vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure). * To exclude sexually active male participants with WOCBP partners who are unwilling to use the one of the following forms of medically acceptable birth control at start of the first treatment, during the study, and for at least 6 months after the last dose: * vasectomy with medical assessment of surgical success OR consistent use of a condom. * male participants must also agree not to donate sperm while receiving study drug and for at least 6 months after the last dose. * Patients receiving strong CYP 3A4 inducers during study period * Patients with major ABO mismatch donors only
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hematopoietic cell transplantation (HCT) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Half-Matched stem cells tested as cure for myelofibrosis
- Can blood tests predict transplant complications?
- Can a new daily pill shrink the spleen and ease myelofibrosis symptoms?
- Can a new pill tame myelofibrosis?
- MRI as a window into bone marrow disease: a new biomarker test?
- Can a menin inhibitor tame myelofibrosis when standard drugs fall short?