Can a pre-transplant drug help new marrow take hold?
NCT ID NCT07883382
First seen Oct 20, 2026 · Last updated Oct 21, 2026 · Updated 1 time
Summary
Researchers are testing whether gecacitinib, an oral drug, can improve outcomes for people with myeloid neoplasms and myelofibrosis who are scheduled for a donor stem cell transplant. About 10 participants will take gecacitinib starting 13 weeks before transplant, through the transplant period, and for up to 24 weeks after their marrow starts working again. The main goal is to see how many patients achieve successful engraftment by day 28 after transplant. The study also tracks graft failure, severe graft-versus-host disease, survival, infections, and changes in bone marrow scarring.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gecacitinib, an oral tablet given around the time of a donor stem cell transplant
- What this could lead to
- If it works, gecacitinib could help donor stem cells settle in faster and lower the risk of graft failure and severe graft-versus-host disease after transplant.
- What could go wrong
- This is a very small, single-center early-phase study with no control group, so any benefit could be due to chance or not apply to other patients. Gecacitinib may also cause side effects that outweigh its benefits.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
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 years and older
- 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. Patients must voluntarily sign the informed consent form, be aged ≥18 years at the time of informed consent, and may be of either sex. 2. Diagnosed with myeloid neoplasms according to 2022 WHO diagnostic criteria 3. Bone marrow fibrosis grade ≥2 according to 2016 WHO myelofibrosis grading criteria 4. Undergoing first allogeneic hematopoietic stem cell transplantation 5. ECOG performance status: 0-2 6. Able to swallow tablets 7. Able to comply with study procedures and follow-up requirements Exclusion Criteria: 1. Currently receiving JAK inhibitors other than gecacitinib at screening (patients who have switched from other JAK inhibitors to gecacitinib before screening are eligible) 2. Prior allogeneic hematopoietic stem cell transplantation or organ transplantation 3. Uncontrolled severe infection, shock, severe organ failure, or any other condition that would preclude tolerance of the study treatment at enrollment. 4. Any significant clinical or laboratory abnormality that may affect safety evaluation, including: 1. Uncontrolled diabetes (fasting blood glucose \>13.9 mmol/L) 2. Uncontrolled hypertension despite ≥2 antihypertensive drugs (SBP ≥160 mmHg or DBP ≥100 mmHg) 3. Peripheral neuropathy (NCI-CTC AE v5.0 grade ≥2) 4. Serum creatinine \>1.5×ULN 5. ALT or AST \>2.5×ULN; DBIL or TBIL \>2.0×ULN 5. Any of the following within 6 months before screening: NYHA class III-IV congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accident, or pulmonary embolism; arrhythmia requiring treatment; or QTcB \>480 ms. 6. Known active gastrointestinal ulcer at screening, or a history of gastrectomy or intestinal resection that may affect drug absorption. 7. Major surgery within 4 weeks before screening without full recovery 8. Known HIV infection and/or AIDS 9. History of tuberculosis infection 10. Epilepsy or use of psychotropic/sedative drugs at screening 11. Pregnant or breastfeeding women; patients unable to use effective contraception throughout the study period 12. Any other comorbidity that may affect the study or prior malignancy 13. Treatment with anticoagulant or antiplatelet drugs (except low molecular weight heparin) 14. Other severe conditions that, in the investigator's judgment, may affect patient safety or compliance 15. Known hypersensitivity to gecacitinib hydrochloride, drugs of the same class, or any excipients 16. Participation in other investigational drug or medical device clinical trials within 3 months before screening 17. Any comorbidity or prior malignancy that, in the investigator's judgment, may affect study participation, safety evaluation, or interpretation of study results.
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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 places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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No. 197, Ruijin Second Road, Shanghai
Shanghai, China