Myelofibrosis (MF)Phase 2CONTINUUM-MFNCT07471503
Gecacitinib Pre-, During- and Post-HSCT for Patients With Primary or Secondary Myelofibrosis
A Phase 2 study testing Gecacitinib (also known as Jaktinib) in people with Myelofibrosis (MF) and HSCT, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
The investigators evaluate the efficacy and safety of Gecacitinib in patients with myelofibrosis (MF) before, during, and after 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 (MF), HSCT
- What is being tested?
- Gecacitinib (also known as Jaktinib)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 16 Mar 2026to 1 Apr 2030
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years, regardless of gender;
- 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;
- Meeting the criteria for intermediate-risk or high-risk groups per the DIPSS-plus classification;
- Scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT), including transplants from HLA-matched or mismatched related or unrelated donors;
- ECOG performance status ≤2 and Karnofsky performance status ≥60%;
- Capable of understanding and signing the informed consent form, and able to comply with study and follow-up procedures.
Who cannot join
- 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.
- Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation.
- Disease progression to accelerated or blast phase (peripheral blood or bone marrow blast percentage ≥10% at any time prior to transplantation).
- Presence of significant medical conditions or marked organ dysfunction that cannot be adequately controlled and may affect the completion of this study:
- 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.
- Uncontrolled diabetes (>250 mg/dL or >13.9 mmol/L).
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- Hypertension that cannot be reduced to the following range despite combination antihypertensive therapy (systolic blood pressure <160 mmHg, diastolic blood pressure <100 mmHg).
- Peripheral neuropathy (≥ Grade 2 per NCI-CTC AE v5.0 criteria).
- Serum creatinine >1.5 × ULN.
- ALT or AST >2.5 × ULN, or DBIL or TBIL >2.0 × ULN.
- Patients with any bacterial, viral, or fungal infection not adequately controlled.
- 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.
- History of tuberculosis or positive interferon-gamma release assay at screening.
- Suspected hypersensitivity to Gecacitinib Hydrochloride, drugs of the same class, or any of their excipients.
- Pregnant or breastfeeding women, or patients unwilling to use effective contraception during Gecacitinib treatment and for one week after the last dose.
- Patients with any other comorbidities that may interfere with the study or a history of prior malignancies.
- Patients unable to take oral tablets.
About this study
Official title: A Phase 2 Clinical Study of Gecacitinib in Peri-transplant Period of Hematopoietic Stem Cell Transplantation in Patients With Myelofibrosis (MF)
The investigators evaluate the efficacy and safety of Gecacitinib in patients with myelofibrosis (MF) before, during, and after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Conditions
- Myelofibrosis (MF), HSCT
- Being tested
- Gecacitinib (also known as Jaktinib)
- Keywords
- myelofibrosis, HSCT, 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 (also known as Jaktinib)Drug
Gecacitinib treatment is initiated or continued at least two weeks before transplantation (Day -14) at a dose of 50 mg bid. This dose is maintained during preconditioning and the transplantation period until hematopoietic reconstitution, after which the dose is increased to 100 mg bid once platelet count recovers to ≥50×10⁹/L and absolute neutrophil count (ANC) recovers to ≥0.5×10⁹/L. The 100 mg bid dose is maintained until six months post-transplantation, after which it is adjusted to 50 mg bid until one year post-transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Gecacitinib treatment | Experimental | Not described Receives: Drug: Gecacitinib (also known as Jaktinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year GVHD-free and relapse-free survival (GRFS) rate from the date of transplant
GRFS is defined as the absence of grade 3 to 4 acute GVHD, chronic GVHD requiring systemic immunosuppressive treatment, disease relapse, and death.
Measured: 1 year post-HSCT
Secondary outcomes (9)
Cumulative incidence of aGVHD
Cumulative incidence of grades II-IV and II-IV acute GVHD at +100 days and 6 months after HSCT
Measured: +100 days and 6 months post-HSCT
Cumulative incidence of cGVHD
Cumulative incidence of moderate to severe chronic GVHD at 6 months and 1 year post-HSCT
Measured: 6 months and 1 year post-HSCT
The molecular relapse rate of MF
The molecular relapse rate of MF at 1 year post-HSCT.
Measured: 1 year post-HSCT
Non-relapse mortality (NRM) rates
Non-relapse mortality (NRM) is defined as non-relapse death due to any cause without the recurrence or progression of myelofibrosis.
Measured: 6 months and 1 year post-HSCT
Rate of Engraftment
Engraftment is defined as the patient achieving peripheral blood neutrophil counts >0.5×10⁹/L for three consecutive days and platelet counts >20×10⁹/L for seven consecutive days, without the need for platelet transfusion.
Measured: 100 days post-HSCT
Proportion of patients with baseline splenomegaly achieving a ≥35% reduction in spleen volume.
Proportion of patients with baseline splenomegaly (palpable spleen edge at or beyond at least 5 cm below the costal margin) achieving a ≥35% reduction from baseline in spleen volume.
Measured: 100 days, 6 months, and 1 year post-HSCT
Overall Survival
Overall survival is measured as the time from the hematopoietic stem cell transplantation (HSCT) until death. Participants without an event will be censored at the date of last contact.
Measured: 1 year post-HSCT
Progression Free Survival (PFS)
PFS is defined as the time from the date of the first stem cell infusion until death from any cause, disease progression, or hematological relapse, whichever occurs first.
Measured: 1 year post-HSCT
Toxicity rate
Cumulative incidence of treatment related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0). Early deaths from all other causes are considered a competing risk.
Measured: From the first dose to 28 days after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start16 Mar 2026 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelofibrosis (MF)Studies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471503
- Sponsor's protocol ID
- IIT2026005
- Acronym
- CONTINUUM-MF
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Study of Gecacitinib in Peri-transplant Period of Hematopoietic Stem Cell Transplantation in Patients With Myelofibrosis (MF)
- ClinicalTrials.gov ID
- NCT07471503
- Acronym / sponsor ID
- CONTINUUM-MF / IIT2026005
- Conditions
- Myelofibrosis (MF), HSCT
- Keywords
- myelofibrosis, HSCT, Gecacitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 16 Mar 2026 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 13 Mar 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.
The investigators evaluate the efficacy and safety of Gecacitinib in patients with myelofibrosis (MF) before, during, and after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gecacitinib treatment | Experimental | Drug: Gecacitinib (also known as Jaktinib) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-75 years, regardless of gender;
- 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;
- Meeting the criteria for intermediate-risk or high-risk groups per the DIPSS-plus classification;
- Scheduled to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT), including transplants from HLA-matched or mismatched related or unrelated donors;
- ECOG performance status ≤2 and Karnofsky performance status ≥60%;
Key exclusion criteria (17 listed)
- 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.
- Patients who have previously undergone allogeneic hematopoietic stem cell transplantation or organ transplantation.
- Disease progression to accelerated or blast phase (peripheral blood or bone marrow blast percentage ≥10% at any time prior to transplantation).
- Presence of significant medical conditions or marked organ dysfunction that cannot be adequately controlled and may affect the completion of this study:
- Patients with any bacterial, viral, or fungal infection not adequately controlled.
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 |
|---|---|---|
| Gecacitinib (also known as Jaktinib)Gecacitinib treatment is initiated or continued at least two weeks before transplantation (Day -14) at a dose of 50 mg bid. This dose is maintained during preconditioning and the transplantation period until hematopoietic reconstitution, after which the dose is increased to 100 mg bid once platelet count recovers to ≥50×10⁹/L and absolute neutrophil count (ANC) recovers to ≥0.5×10⁹/L. The 100 mg bid dose is maintained until six months post-transplantation, after which it is adjusted to 50 mg bid until one year post-transplantation. | Drug | Gecacitinib treatment |
Primary outcome
1-year GVHD-free and relapse-free survival (GRFS) rate from the date of transplant
Time frame: 1 year post-HSCT
GRFS is defined as the absence of grade 3 to 4 acute GVHD, chronic GVHD requiring systemic immunosuppressive treatment, disease relapse, and death.
9 secondary outcomes
Cumulative incidence of aGVHD
Time frame: +100 days and 6 months post-HSCT
Cumulative incidence of cGVHD
Time frame: 6 months and 1 year post-HSCT
The molecular relapse rate of MF
Time frame: 1 year post-HSCT
Non-relapse mortality (NRM) rates
Time frame: 6 months and 1 year post-HSCT
Rate of Engraftment
Time frame: 100 days post-HSCT
Proportion of patients with baseline splenomegaly achieving a ≥35% reduction in spleen volume.
Time frame: 100 days, 6 months, and 1 year post-HSCT
Overall Survival
Time frame: 1 year post-HSCT
Progression Free Survival (PFS)
Time frame: 1 year post-HSCT
Toxicity rate
Time frame: From the first dose to 28 days after the last dose.
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 13 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gecacitinib (also known as Jaktinib) in people with Myelofibrosis (MF) and HSCT, run by Institute of Hematology & Blood Diseases Hospital, 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 6 inclusion and 17 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 13 Mar 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.
What does this phase mean?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year GVHD-free and relapse-free survival (GRFS) rate from the date of transplant (time frame: 1 year post-HSCT). 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 13 Mar 2026.