New drug combo may boost stem cell success in rare bone marrow cancer
NCT ID NCT07471503
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug gecacitinib, given before, during, and after a stem cell transplant, can help people with myelofibrosis (a type of bone marrow cancer) have better outcomes. About 39 adults aged 18-75 with intermediate- or high-risk myelofibrosis will take part. The goal is to see if the drug reduces serious complications like graft-versus-host disease and relapse, while improving survival.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 39 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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: 1. Aged 18-75 years, regardless of gender; 2. Diagnosis of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV-MF), or post-essential thrombocythemia myelofibrosis (post-ET-MF) according to the 2022 WHO diagnostic criteria; 3. Meeting the criteria for intermediate-risk or high-risk groups per the DIPSS-plus classification; 4. Scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT), including transplants from HLA-matched or mismatched related or unrelated donors; 5. ECOG performance status ≤2 and Karnofsky performance status ≥60%; 6. Capable of understanding and signing the informed consent form, and able to comply with study and follow-up procedures. Exclusion Criteria: 1. Patients using other JAK inhibitors (except for Gecacitinib) at the time of screening may be enrolled if they switch to Gecacitinib treatment prior to screening. 2. Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation. 3. Disease progression to accelerated or blast phase (peripheral blood or bone marrow blast percentage ≥10% at any time prior to transplantation). 4. Presence of significant medical conditions or marked organ dysfunction that cannot be adequately controlled and may affect the completion of this study: 1. Congestive heart failure classified as New York Heart Association (NYHA) Class III-IV, or documented history of diastolic or systolic dysfunction (e.g., LVEF \<40% measured by echocardiography), or uncontrolled or unstable angina or myocardial infarction. 2. Uncontrolled diabetes (\>250 mg/dL or \>13.9 mmol/L). 3. Hypertension that cannot be reduced to the following range despite combination antihypertensive therapy (systolic blood pressure \<160 mmHg, diastolic blood pressure \<100 mmHg). 4. Peripheral neuropathy (≥ Grade 2 per NCI-CTC AE v5.0 criteria). 5. Serum creatinine \>1.5 × ULN. 6. ALT or AST \>2.5 × ULN, or DBIL or TBIL \>2.0 × ULN. 5. Patients with any bacterial, viral, or fungal infection not adequately controlled. 6. HIV-positive at screening, or active hepatitis B virus infection (HBsAg-positive with HBV-DNA positivity or above the normal reference range), or HCV antibody-positive with HCV-RNA positivity. 7. History of tuberculosis or positive interferon-gamma release assay at screening. 8. Suspected hypersensitivity to Gecacitinib Hydrochloride, drugs of the same class, or any of their excipients. 9. Pregnant or breastfeeding women, or patients unwilling to use effective contraception during Gecacitinib treatment and for one week after the last dose. 10. Patients with any other comorbidities that may interfere with the study or a history of prior malignancies. 11. Patients unable to take oral tablets.
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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.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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