An interventional study of Peri-Transplant Gecacitinib in Myelofibrosis, Primary Myelofibrosis (PMF) and Secondary Myelofibrosis, sponsored by First Affiliated Hospital of Zhejiang University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by First Affiliated Hospital of Zhejiang University · Not applicable, Interventional, and Treatment
This study aims to evaluate the efficacy, safety, and feasibility of peri-transplant gecacitinib in patients with myelofibrosis undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Myelofibrosis is a bone marrow disorder that can cause reduced blood cell production, enlargement of the spleen, and other complications. Allogeneic stem cell transplantation offers a potential cure, but its benefits may be limited by graft-versus-host disease (GVHD), disease relapse, and transplant-related complications.
This is a multicenter, prospective, open-label, single-arm clinical study. Participants will receive gecacitinib before, during, and after transplantation, together with standard transplantation care and GVHD prophylaxis.
The primary objective is to evaluate GVHD-free, relapse-free survival (GRFS) at 1 year after transplantation. GRFS measures survival without severe acute GVHD, chronic GVHD requiring systemic immunosuppressive treatment, disease relapse or progression, or death.
The study plans to enroll approximately 46 participants, with 43 expected to be evaluable for the primary endpoint. Participants will be followed for up to 2 years after transplantation. Secondary assessments include overall survival, progression-free survival, GVHD, disease relapse, non-relapse mortality, hematopoietic engraftment, treatment feasibility, and safety.
ackground and Rationale
Myelofibrosis (MF) is a chronic myeloproliferative neoplasm characterized by progressive bone marrow fibrosis, abnormal hematopoiesis, splenomegaly, constitutional symptoms, and an increased risk of leukemic transformation. Myelofibrosis includes primary myelofibrosis (PMF) and secondary myelofibrosis arising from polycythemia vera or essential thrombocythemia.
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only potentially curative treatment for eligible patients with myelofibrosis. However, transplantation is associated with substantial risks of graft-versus-host disease (GVHD), graft failure, disease relapse, and non-relapse mortality, which may compromise long-term clinical outcomes.
Janus kinase (JAK) inhibitors have demonstrated clinical benefits in controlling splenomegaly and constitutional symptoms in patients with myelofibrosis. Nevertheless, the optimal strategy for JAK inhibitor administration before, during, and after allo-HSCT remains uncertain.
Gecacitinib is an orally administered JAK inhibitor used for the treatment of myelofibrosis. This study aims to investigate whether a continuous peri-transplant gecacitinib strategy is feasible and safe and whether it may improve post-transplant outcomes.
Study Design
This is a multicenter, prospective, open-label, single-arm clinical study evaluating peri-transplant gecacitinib in patients with primary or secondary myelofibrosis undergoing allo-HSCT.
Approximately 46 participants will be enrolled to obtain 43 evaluable participants for the primary efficacy analysis.
All participants will receive gecacitinib in addition to protocol-defined standard transplantation care and GVHD prophylaxis. There is no randomized allocation or concurrent control group.
Treatment Strategy
Gecacitinib treatment will begin on Day -14 before transplantation and will be continued through the conditioning, transplantation, and post-transplant periods, subject to protocol-defined safety assessments and dose modifications.
The recommended initial oral dose is 50 mg twice daily for participants with a baseline platelet count of at least 50 × 10\^9/L, or 50 mg once daily for participants with a baseline platelet count below 50 × 10\^9/L.
After hematopoietic engraftment, dose escalation may be considered according to hematologic recovery, treatment tolerance, disease-related symptoms, and the investigator's assessment. Dose reductions, temporary interruptions, and treatment discontinuation will be implemented according to protocol-defined criteria for hematologic and nonhematologic toxicities, infections, organ dysfunction, and potential drug interactions.
Gecacitinib treatment may continue for up to 1 year after transplantation.
Study Objectives and Endpoints
The primary objective is to evaluate the 1-year GVHD-free, relapse-free survival (GRFS) following allo-HSCT.
GRFS is defined as survival without any of the following events: grade III-IV acute GVHD, chronic GVHD requiring systemic immunosuppressive treatment, relapse or progression of myelofibrosis, or death.
Secondary objectives include the evaluation of overall survival, progression-free survival, the incidence and severity of acute and chronic GVHD, disease relapse or progression, non-relapse mortality, hematopoietic engraftment, treatment feasibility, and safety.
Exploratory assessments will investigate donor chimerism dynamics, immune reconstitution, and changes in selected cytokine-related biomarkers and their potential associations with clinical outcomes.
Statistical Considerations
The study uses a single-arm threshold-based design. The historical 1-year GRFS rate is assumed to be 20%, and the target rate is 40%.
A total of 43 evaluable participants is planned. Achievement of 1-year GRFS in at least 13 of these 43 participants will meet the prespecified efficacy threshold.
Kaplan-Meier methods will be used to estimate survival outcomes. Competing-risk methods will be applied to appropriate transplant-related endpoints, including GVHD, relapse, and non-relapse mortality. Safety will be evaluated by summarizing adverse events, serious adverse events, and treatment modifications.
Follow-up
Participants will undergo scheduled clinical and laboratory assessments throughout treatment and follow-up. These assessments will include hematologic recovery, disease status, GVHD, infectious complications, adverse events, donor chimerism, and immune reconstitution as applicable.
Participants will be followed for 2 years after transplantation to assess survival, disease control, transplant-related complications, and long-term safety.
625 studies on the registry are indexed under Primary Myelofibrosis; 124 are open to participants now.
This study's planned enrollment of 46 is close to the median of 43 across 489 interventional studies indexed under Primary Myelofibrosis.
Browse Primary Myelofibrosis studies →First Affiliated Hospital of Zhejiang University is the lead sponsor of 263 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must meet at least one of the following disease risk criteria:
Intermediate-2 or high-risk disease according to the Dynamic International Prognostic Scoring System Plus (DIPSS-plus).
Intermediate-1 risk disease according to DIPSS-plus with at least one of the following adverse features:
Red blood cell transfusion dependence.
Unfavorable cytogenetic abnormalities, including trisomy 8 (+8), monosomy 7 or deletion 7q (-7/del(7q)), isochromosome 17q [i(17q)], inversion 3 [inv(3)] or abnormalities involving 3q21, monosomy 5 or deletion 5q (-5/del(5q)), deletion 12p [del(12p)], or 11q23 rearrangements.
count ≤100 × 10\^9/L.
High-risk molecular abnormalities associated with adverse prognosis, including ASXL1, EZH2, IDH1, IDH2, SRSF2, U2AF1, or TP53 mutations.
Exclusion Criteria:
uncontrolled infection with virus (HBV), virus (HCV), or (HIV). Patients with controlled chronic infections may be eligible if they meet protocol-defined conditions, including:
HBV: appropriate antiviral management without evidence of active hepatitis. HCV: no acute hepatitis or hepatic decompensation, with acceptable liver function.
HIV: stable antiretroviral therapy, undetectable HIV viral load, and ≥350 cells/μL.
Significant hepatic impairment, including any of the following:
, ALT, or alkaline phosphatase ≥3 × the (ULN). Direct >2.0 mg/dL. Total bilirubin >1.5 × ULN.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with primary or secondary myelofibrosis undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) will receive oral gecacitinib starting on Day -14 before transplantation and continuing through conditioning, transplantation, and the post-transplant period. The initial dose will be 50 mg twice daily for patients with baseline platelet counts ≥50 × 10\^9/L or 50 mg once daily for those with platelet counts below 50 × 10\^9/L. Dose adjustments, interruptions, and escalation after engraftment will follow protocol-defined criteria. Treatment may continue for up to 1 year after transplantation. All participants will also receive standard transplantation care and GVHD prophylaxis.
Drug: Peri-Transplant Gecacitinib
Gecacitinib will be administered orally starting on Day -14 before allogeneic hematopoietic stem cell transplantation (allo-HSCT) and continued throughout conditioning, transplantation, and the post-transplant period. The initial dose will be 50 mg twice daily (BID) for participants with baseline platelet counts ≥50 × 10\^9/L or 50 mg once daily (QD) for those with platelet counts below 50 × 10\^9/L. After hematopoietic engraftment, dose escalation up to 100 mg BID may be considered based on hematologic recovery, treatment tolerability, and disease control. Dose reductions, temporary interruptions, and treatment discontinuation will follow protocol-defined criteria for adverse events, infections, organ dysfunction, and drug interactions. Treatment may continue for up to 1 year after transplantation. All participants will receive standard transplantation care and GVHD prophylaxis.
1-Year GVHD-Free, Relapse-Free Survival (GRFS)
The proportion of participants alive at 1 year after allogeneic hematopoietic stem cell transplantation without any of the following events: grade III-IV acute graft-versus-host disease (GVHD), chronic GVHD requiring systemic immunosuppressive treatment, relapse or progression of myelofibrosis, or death from any cause. The first occurrence of any component event will be considered a GRFS event. Acute GVHD will be graded according to MAGIC criteria, and chronic GVHD will be assessed according to the 2014 NIH consensus criteria.
Time frame: From transplantation (Day 0) to 12 months after transplantation
Progression-Free Survival（PFS）
PFS is defined as the time from transplantation to the first occurrence of myelofibrosis relapse or progression, or death from any cause. PFS probabilities will be estimated using the Kaplan-Meier method.
Time frame: At 12 months after transplantation
Overall Survival（OS）
OS is defined as the time from transplantation to death from any cause. Participants alive at the last follow-up will be censored. OS probabilities will be estimated using the Kaplan-Meier method.
Time frame: At 12 months after transplantation
Cumulative Incidence of Grade II-IV Acute GVHD
Cumulative incidence of grade II-IV acute graft-versus-host disease assessed according to the MAGIC criteria. Death without prior acute GVHD will be treated as a competing event.
Time frame: From transplantation to Day +180
Cumulative Incidence of Grade III-IV Acute GVHD
Cumulative incidence of grade III-IV acute graft-versus-host disease assessed according to the MAGIC criteria. Death without prior acute GVHD will be treated as a competing event.
Time frame: From transplantation to Day +180
Cumulative Incidence of Moderate-to-Severe Chronic GVHD
Cumulative incidence of moderate-to-severe chronic graft-versus-host disease assessed according to the 2014 NIH consensus criteria. Death without prior chronic GVHD will be treated as a competing event.
Time frame: At 12 months after transplantation
Cumulative Incidence of Non-Relapse Mortality (NRM)
Cumulative incidence of death without prior relapse or progression of myelofibrosis. Disease relapse or progression will be considered a competing event.
Time frame: At 6 and 12 months after transplantation
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Zhejiang University →