Gecacitinib Pre-, During- and Post-HSCT for Patients With Primary or Secondary Myelofibrosis

NCT07471503 | Not Yet Recruiting Phase 2

• 1 other identifier: IIT2026005
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Myelofibrosis (MF); HSCT

Keywords

myelofibrosis; HSCT; Gecacitinib

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year post-HSCT

Secondary Outcomes (9)

• Cumulative incidence of aGVHD

  +100 days and 6 months post-HSCT

• Cumulative incidence of cGVHD

  6 months and 1 year post-HSCT

• The molecular relapse rate of MF

  1 year post-HSCT

• Non-relapse mortality (NRM) rates

  6 months and 1 year post-HSCT

• Rate of Engraftment

  100 days post-HSCT

Other Outcomes (2)

• Changes in absolute counts of lymphocyte subsets

  3 months, 6 months, and 1 year.

• Changes in concentrations of immunoglobulins

  3 months, 6 months, and 1 year

Study Arms (1)

Gecacitinib treatment

EXPERIMENTAL

Drug: Gecacitinib (also known as Jaktinib)

Interventions

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.

Gecacitinib treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 13, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2030
• Last Updated: March 13, 2026

Record last verified: 2026-03