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Myeloid Neoplasms With MyelofibrosisPhase 1/2JAK-PeriMFNCT07883382

An Exploratory Study on the Use of Gecacitinib in Patients With Myeloid Malignancies and Myelofibrosis During the Peri-transplant Period Following Allogeneic Hematopoietic Stem Cell Transplantation

A Phase 1/2 study testing gecacitinib Hydrochloride Tablets in people with Myeloid Neoplasms With Myelofibrosis, run by Ruijin Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a single-arm, single-center exploratory study evaluating the safety and efficacy of gecacitinib administered in the peri-transplant period in patients with myeloid neoplasms and myelofibrosis (MF) who are scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).Approximately 10… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloid Neoplasms With Myelofibrosis
What is being tested?
gecacitinib Hydrochloride Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
15 Oct 2026to 30 Sep 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must voluntarily sign the informed consent form, be aged ≥18 years at the time of informed consent, and may be of either sex.
  • Diagnosed with myeloid neoplasms according to 2022 WHO diagnostic criteria
  • Bone marrow fibrosis grade ≥2 according to 2016 WHO myelofibrosis grading criteria
  • Undergoing first allogeneic hematopoietic stem cell transplantation
  • ECOG performance status: 0-2
  • Able to swallow tablets
  • Able to comply with study procedures and follow-up requirements

Who cannot join

  • Currently receiving JAK inhibitors other than gecacitinib at screening (patients who have switched from other JAK inhibitors to gecacitinib before screening are eligible)
  • Prior allogeneic hematopoietic stem cell transplantation or organ transplantation
  • Uncontrolled severe infection, shock, severe organ failure, or any other condition that would preclude tolerance of the study treatment at enrollment.
  • Any significant clinical or laboratory abnormality that may affect safety evaluation, including:
  • Uncontrolled diabetes (fasting blood glucose >13.9 mmol/L)
  • Uncontrolled hypertension despite ≥2 antihypertensive drugs (SBP ≥160 mmHg or DBP ≥100 mmHg)
Show all 22Show fewer
  • Peripheral neuropathy (NCI-CTC AE v5.0 grade ≥2)
  • Serum creatinine >1.5×ULN
  • ALT or AST >2.5×ULN; DBIL or TBIL >2.0×ULN
  • 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.
  • Known active gastrointestinal ulcer at screening, or a history of gastrectomy or intestinal resection that may affect drug absorption.
  • Major surgery within 4 weeks before screening without full recovery
  • Known HIV infection and/or AIDS
  • History of tuberculosis infection
  • Epilepsy or use of psychotropic/sedative drugs at screening
  • Pregnant or breastfeeding women; patients unable to use effective contraception throughout the study period
  • Any other comorbidity that may affect the study or prior malignancy
  • Treatment with anticoagulant or antiplatelet drugs (except low molecular weight heparin)
  • Other severe conditions that, in the investigator's judgment, may affect patient safety or compliance
  • Known hypersensitivity to gecacitinib hydrochloride, drugs of the same class, or any excipients
  • Participation in other investigational drug or medical device clinical trials within 3 months before screening
  • Any comorbidity or prior malignancy that, in the investigator's judgment, may affect study participation, safety evaluation, or interpretation of study results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zilu Zhang, PhD contact

021-64370045

zzl12402@rjh.com.cn

China1 site, 1 recruiting
  • No. 197, Ruijin Second Road, Shanghai

    Shanghai

    Zilu Zhang, PhD, 021-64370045, zzl12402@rjh.com.cn

    Recruiting

Other trials in China

About this study

Official title: An Exploratory Study of Gecacitinib in the Peri-Transplant Period for Patients With Myeloid Neoplasms and Myelofibrosis Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

This is a single-arm, single-center exploratory study evaluating the safety and efficacy of gecacitinib administered in the peri-transplant period in patients with myeloid neoplasms and myelofibrosis (MF) who are scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).Approximately 10 eligible patients will receive oral gecacitinib starting 13 weeks before transplantation. Treatment will continue through the peri-transplant period and for up to 24 weeks after hematopoietic reconstitution. The primary endpoint is the engraftment rate at day +28 post-transplant. Secondary endpoints include poor graft function rate, grade III-IV acute GVHD rate, overall survival, infection rate, and bone marrow fibrosis grade changes.

Read the detailed description

Background: Myelofibrosis (MF) and other myeloid neoplasms with myelofibrosis are associated with significant clinical symptoms that can adversely affect the outcomes of allogeneic hematopoietic stem cell transplantation (allo-HSCT). JAK inhibitors are recommended as bridging therapy before transplantation in MF patients with high symptom burden, but the optimal peri-transplant management strategy remains an area of active investigation.

Gecacitinib is a next-generation JAK inhibitor that has demonstrated superior efficacy and a better hematologic safety profile than ruxolitinib in previous studies. In frontline patients with MF, treatment with gecacitinib resulted in a spleen volume response rate (SVR35) of 64.8%, significantly higher than ruxolitinib (27%), with a lower incidence of anemia than that observed with ruxolitinib (36.6% vs. 50.8%). Preclinical studies have also shown that gecacitinib can prolong survival and alleviate GVHD in a huPBMC-NCG mouse model.

Study Design: This is a single-arm, single-center, exploratory clinical study. Approximately 10 patients with myeloid neoplasms and bone marrow fibrosis of grade ≥2 who are scheduled to undergo their first allo-HSCT will be enrolled.

Intervention: gecacitinib will be administered orally starting 13 weeks before transplantation. The starting dose is determined by baseline platelet count: 100 mg BID for platelets ≥50×10^9/L, or 50 mg BID for platelets <50×10^9/L. The dose will be reduced to 50 mg BID beginning 1 week before transplantation (day -7) and will be maintained at this dose during conditioning and transplantation, then increased to 100 mg BID after hematopoietic reconstitution (PLT ≥50×10^9/L and ANC ≥0.5×10^9/L), maintained for 12 weeks, then tapered to 50 mg BID for another 12 weeks before discontinuation.

Primary Outcome: Engraftment rate at day +28 post-transplant (defined as neutrophil count >0.5×10^9/L for 3 consecutive days and platelet count >20×10^9/L for 7 consecutive days without platelet transfusion support).

Follow-up: Patients will be followed for 2 years after transplantation or until death or loss to follow-up, whichever occurs first.

Being tested
gecacitinib Hydrochloride Tablets
Keywords
Myelofibrosis, Myeloid Neoplasms, Allogeneic Hematopoietic Stem Cell Transplantation, JAK Inhibitor, gecacitinib
Medical subject headings
Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gecacitinib Hydrochloride TabletsDrug

    gecacitinib is administered orally, starting 13 weeks before allo-HSCT. Starting dose is based on baseline platelet count: 100 mg twice daily (BID) if platelets ≥50×10^9/L, or 50 mg BID if platelets <50×10^9/L.The dose will be reduced to 50 mg BID beginning on day -7 (1 week before transplantation) and maintained at this dose during conditioning and transplantation. After hematopoietic reconstitution (PLT ≥50×10^9/L and ANC ≥0.5×10^9/L), the dose is increased to 100 mg BID for 12 weeks, then tapered to 50 mg BID for another 12 weeks before discontinuation.

    Dose adjustments are made based on adverse events and hematologic parameters, with a maximum dose of 100 mg BID and minimum of 50 mg once daily (QD).

Study groups in NCT07883382
Study groupRoleWhat they receive
Experimental: gecacitinib Peri-TransplantExperimentalgecacitinib is administered orally, starting 13 weeks before allo-HSCT. Starting dose is based on baseline platelet count: 100 mg twice daily (BID) if platelets ≥50×10^9/L, or 50 mg BID if platelets <50×10^9/L.The dose will be reduced to 50 mg BID beginning on day -7 (1 week before transplantation) and maintained at this dose during conditioning and transplantation. After hematopoietic reconstitution (PLT ≥50×10^9/L and ANC ≥0.5×10^9/L), the dose is increased to 100 mg BID for 12 weeks, then tapered to 50 mg BID for another 12 weeks before discontinuation.
Receives: Drug: gecacitinib Hydrochloride Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Engraftment Rate at Day +28 Post-Transplant

    Percentage of patients who achieve both neutrophil engraftment (ANC >0.5×10^9/L for 3 consecutive days) and platelet engraftment (PLT >20×10^9/L for 7 consecutive days without platelet transfusion) by day +28 after transplantation.

    Measured: Day +28 post-transplant

Secondary outcomes (6)
  1. Incidence of Poor Graft Function (PGF) at Day +180

    PGF is defined as persistent cytopenia(s), including ANC <0.5×10^9/L, PLT <20×10^9/L or platelet transfusion dependence, and/or Hb <70 g/L or red blood cell transfusion dependence, lasting for at least 2 weeks after initial donor engraftment, with hypoplastic marrow, full donor chimerism, and exclusion of relapse, rejection, severe GVHD, active infection, drug-related myelosuppression, or other identifiable causes.

    Measured: Day +180 post-transplant

  2. Incidence of Grade III-IV Acute Graft-Versus-Host Disease (aGVHD) at Day +180

    Percentage of patients developing grade III-IV acute GVHD within 180 days after transplantation, graded according to standard criteria.

    Measured: Day +180 post-transplant

  3. Overall Survival (OS) at 1 Year Post-Transplant

    Overall survival is defined as the time from transplantation to death from any cause. The 1-year overall survival rate is the percentage of patients alive 1 year after transplantation.

    Measured: 1 year post-transplant

  4. Incidence of Severe Infections Within 180 Days Post-Transplant

    Percentage of patients experiencing grade ≥3 infections within 180 days after transplantation.

    Measured: Within 180 days post-transplant

  5. Bone Marrow Fibrosis Grade Changes at Day +90 and Day +180

    Proportion of patients with decreased, increased, or stable bone marrow fibrosis grade at day +90 and day +180 compared to baseline, assessed according to the 2016 WHO myelofibrosis grading criteria.

    Measured: Day +90 and Day +180 post-transplant

  6. Safety and Tolerability - Adverse Events

    Incidence and severity of treatment-emergent adverse events (TEAEs), graded according to NCI-CTCAE v5.0 criteria.

    Measured: From start of study drug until 28 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2026
  2. Study start15 Oct 2026 (estimated)
  3. Primary completion28 Oct 2028 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Drug: gecacitinib Hydrochloride Tablets
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07883382
Sponsor's protocol ID
20260918051934228
Acronym
JAK-PeriMF
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because the informed consent obtained from participants does not cover external data sharing. Given the sensitive nature of the data and the small study population, sharing de-identified participant-level data may also pose a risk of re-identification. Aggregate results will be reported in study publications.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing gecacitinib Hydrochloride Tablets in people with Myeloid Neoplasms With Myelofibrosis, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zilu Zhang, PhD (021-64370045, zzl12402@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Engraftment Rate at Day +28 Post-Transplant (time frame: Day +28 post-transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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