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New drug combo may boost stem cell success in rare bone marrow cancer

NCT ID NCT07471503

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 39 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Apr 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 to 75 years

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

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

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How to take part

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  1. The official record

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