MyelofibrosisNCT07904871
Peri-Transplant Gecacitinib in Patients With Myelofibrosis Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
A study testing Peri-Transplant Gecacitinib in people with Myelofibrosis and Primary Myelofibrosis (PMF), run by First Affiliated Hospital of Zhejiang University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myelofibrosis, Primary Myelofibrosis (PMF), Secondary Myelofibrosis
- What is being tested?
- Peri-Transplant Gecacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2029
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 75 years.
- Confirmed diagnosis of primary myelofibrosis (PMF) according to World Health Organization (WHO) diagnostic criteria, or secondary myelofibrosis (SMF), including post-polycythemia vera myelofibrosis (post-PV MF) and post-essential thrombocythemia myelofibrosis (post-ET MF), according to International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria.
- 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.
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- 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.
- Platelet count ≤100 × 10^9/L.
- High-risk molecular abnormalities associated with adverse prognosis, including ASXL1, EZH2, IDH1, IDH2, SRSF2, U2AF1, or TP53 mutations.
- Patients must have completed transplantation eligibility assessment and be considered suitable candidates for allogeneic hematopoietic stem cell transplantation (allo-HSCT). Either peripheral blood or bone marrow stem cell grafts are permitted. Donor type is not restricted.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Estimated life expectancy ≥3 months.
- Ability to understand the study requirements and provide written informed consent.
- Ability to receive oral gecacitinib, including the ability to swallow tablets without clinically significant gastrointestinal absorption impairment.
- No active severe infection at initiation of study treatment. Patients with infections may be eligible after adequate infection control.
- Patients previously receiving gecacitinib for myelofibrosis may be enrolled if they satisfy all eligibility criteria and have no history of treatment failure, severe unacceptable gecacitinib-related toxicity, or unresolved grade ≥3 gecacitinib-related adverse events. A washout period is not required for patients continuing gecacitinib treatment.
- Previous myelofibrosis-directed therapies, other than ongoing gecacitinib, must be discontinued at least 7 days or 5 drug elimination half-lives (whichever is longer) before initiation of study treatment on Day -14. Concomitant administration of other JAK inhibitors with gecacitinib is not permitted. Short-term hydroxyurea bridging therapy may be permitted if discontinued before Day -14 in accordance with the washout requirements.
- Previous splenectomy is permitted.
- Women of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during the study and for 6 months after the last dose of gecacitinib. Male participants must agree to use effective contraception according to the protocol.
Who cannot join
- Previous allogeneic hematopoietic stem cell transplantation.
- History or presence of blast-phase myeloproliferative neoplasm at screening, defined as: blast phase: ≥20% blasts in peripheral blood or bone marrow.
- Uncontrolled active infection requiring intensive intravenous antimicrobial treatment or hospitalization. Patients with stable, adequately controlled chronic infections may be considered eligible according to protocol-defined conditions.
- Clinically significant uncontrolled infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (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 CD4 count ≥350 cells/μL.
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- Requirement for concomitant strong CYP3A4 inhibitors that cannot be appropriately managed through gecacitinib dose adjustment, monitoring, or substitution in accordance with the protocol.
- Significant hepatic impairment, including any of the following:
- AST, ALT, or alkaline phosphatase ≥3 × the upper limit of normal (ULN). Direct bilirubin >2.0 mg/dL. Total bilirubin >1.5 × ULN.
- Renal impairment with creatinine clearance ≤60 mL/min, calculated using the Cockcroft-Gault formula.
- Severe cardiac dysfunction, including New York Heart Association (NYHA) class III-IV heart failure or left ventricular ejection fraction (LVEF) <40%.
- Other severe organ dysfunction that, in the investigator's judgment, would preclude safe transplantation or administration of the study treatment.
- History of severe hypersensitivity to gecacitinib or any of its excipients.
- Previous gecacitinib treatment failure, including inadequate clinical response or persistent disease progression despite adequate treatment, requiring alternative myelofibrosis-directed therapy, as determined by the investigator.
- History of severe unacceptable gecacitinib-related toxicity, or unresolved grade ≥3 gecacitinib-related adverse events at screening.
- Pregnancy or breastfeeding, or unwillingness to use effective contraception during the required study period.
- Inability to provide informed consent or serious psychiatric, cognitive, social, or behavioral conditions that may substantially impair protocol adherence, completion of follow-up, or safety assessments.
- Inability to take oral study medication, including swallowing difficulties, severe gastrointestinal malabsorption, persistent vomiting, or other conditions likely to significantly impair oral drug absorption.
- Any other condition that, in the investigator's opinion, may substantially increase study-related risks, compromise adherence, or interfere with the interpretation of study results.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Prospective, Open-Label, Single-Arm Clinical Study of Peri-Transplant Gecacitinib in Patients With Myelofibrosis Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Peri-Transplant Gecacitinib
- Keywords
- Myelofibrosis, Gecacitinib, Allogeneic Hematopoietic Stem Cell Transplantation, JAK Inhibitor, Peri-Transplant Treatment, GVHD-Free, Relapse-Free Survival
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-Transplant GecacitinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Peri-Transplant Gecacitinib | Experimental | 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. Receives: Drug: Peri-Transplant Gecacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From transplantation (Day 0) to 12 months after transplantation
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 6 and 12 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multicenter, prospective, open-label, single-arm interventional study. All eligible participants with primary or secondary myelofibrosis undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) will receive peri-transplant gecacitinib in addition to standard transplantation care and GVHD prophylaxis. Gecacitinib will be administered before, during, and after transplantation according to the study protocol. No randomization or concurrent control group is planned. The primary endpoint is 1-year GVHD-free, relapse-free survival (GRFS).
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, The First Affiliated Hospital of Zhengzhou University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital
- Responsible party
- Principal investigator, Yanmin Zhao, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904871
- Sponsor's protocol ID
- ZJU-MF-GCT-2026
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Open-Label, Single-Arm Clinical Study of Peri-Transplant Gecacitinib in Patients With Myelofibrosis Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07904871
- Acronym / sponsor ID
- ZJU-MF-GCT-2026
- Keywords
- Myelofibrosis, Gecacitinib, Allogeneic Hematopoietic Stem Cell Transplantation, JAK Inhibitor, Peri-Transplant Treatment, GVHD-Free, Relapse-Free Survival
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Ruijin Hospital, The First Affiliated Hospital of Zhengzhou University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multicenter, prospective, open-label, single-arm interventional study. All eligible participants with primary or secondary myelofibrosis undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) will receive peri-transplant gecacitinib in addition to standard transplantation care and GVHD prophylaxis. Gecacitinib will be administered before, during, and after transplantation according to the study protocol. No randomization or concurrent control group is planned. The primary endpoint is 1-year GVHD-free, relapse-free survival (GRFS).
| Arm | Type | Receives |
|---|---|---|
| Peri-Transplant Gecacitinib | Experimental | Drug: Peri-Transplant GecacitinibParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients aged 18 to 75 years.
- Confirmed diagnosis of primary myelofibrosis (PMF) according to World Health Organization (WHO) diagnostic criteria, or secondary myelofibrosis (SMF), including post-polycythemia vera myelofibrosis (post-PV MF) and post-essential thrombocythemia myelofibrosis (post-ET MF), according to International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria.
- 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:
Key exclusion criteria (19 listed)
- Previous allogeneic hematopoietic stem cell transplantation.
- History or presence of blast-phase myeloproliferative neoplasm at screening, defined as: blast phase: ≥20% blasts in peripheral blood or bone marrow.
- Uncontrolled active infection requiring intensive intravenous antimicrobial treatment or hospitalization. Patients with stable, adequately controlled chronic infections may be considered eligible according to protocol-defined conditions.
- Clinically significant uncontrolled infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peri-Transplant GecacitinibGecacitinib 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. | Drug | Peri-Transplant Gecacitinib |
Primary outcome
1-Year GVHD-Free, Relapse-Free Survival (GRFS)
Time frame: From transplantation (Day 0) to 12 months after transplantation
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.
6 secondary outcomes
Progression-Free Survival（PFS）
Time frame: At 12 months after transplantation
Overall Survival（OS）
Time frame: At 12 months after transplantation
Cumulative Incidence of Grade II-IV Acute GVHD
Time frame: From transplantation to Day +180
Cumulative Incidence of Grade III-IV Acute GVHD
Time frame: From transplantation to Day +180
Cumulative Incidence of Moderate-to-Severe Chronic GVHD
Time frame: At 12 months after transplantation
Cumulative Incidence of Non-Relapse Mortality (NRM)
Time frame: At 6 and 12 months after transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Peri-Transplant Gecacitinib in people with Myelofibrosis and Primary Myelofibrosis (PMF), run by First Affiliated Hospital of Zhejiang University.
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 19 inclusion and 19 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Hengwei Wu, MD (057187236706, cctv3194495@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year GVHD-Free, Relapse-Free Survival (GRFS) (time frame: From transplantation (Day 0) to 12 months after transplantation). 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 29 Oct 2026.