Actively Recruiting
Exploratory Clinical Study of JAK1 Inhibitor Golidocitnib in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas: An Open, Prospective, Exploratory Clinical Trial
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-11-18
48
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
T
Tianjin First Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Indolent T/NK-cell lymphomas are a group of slow-growing lymphoproliferative diseases originating from T and NK cells, which currently have no cure. For patients whose disease does not respond to initial treatments, options are limited and outcomes are poor. This Phase 2 clinical trial aims to explore the feasibility, effectiveness, and safety of using the JAK1 inhibitor Golidocitnib to treat relapsed or refractory indolent T/NK-cell lymphomas. In this open-label study, 48 patients will receive oral Golidocitnib at a dose of 150 mg once daily in 28-day cycles. Treatment will continue for up to 24 cycles or until disease progression, lack of response within the first 6 cycles, or intolerable side effects occur. Effectiveness will be assessed every cycle during the first year and every two cycles thereafter. Participants will undergo regular evaluations including assessments of response to treatment and monitoring for safety throughout the study, which may last up to 5 years for outcome measures. Key outcomes include overall response rate, complete remission rate, duration of remission, progression-free survival, and overall survival. The study also includes monitoring of side effects and disease control over time to evaluate the impact of Golidocitnib in this patient population.
CONDITIONS
Brief Title
JAK1 Inhibitor Golidocitnib for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed relapsed or refractory indolent T/NK-cell lymphoma
- Disease failed at least one systemic therapy or intolerant to such treatment
- Meets criteria for appropriate therapeutic indications
- ECOG performance status between 0 and 2
- Adequate organ function based on specified laboratory values and heart function
- Expected survival time of at least 3 months
- Use of effective contraception during and for 6 months after treatment if of childbearing potential
- At least 4 weeks washout after any prior antitumor therapies before enrollment
- No participation in other clinical trials within 1 month prior to enrollment
- Signed informed consent form
You will not qualify if you...
- Previous use of any JAK inhibitors
- Chronic gastrointestinal diseases that affect drug absorption or compliance
- Active infections requiring treatment such as pneumonia
- Hepatitis B or C virus infections with active viral replication
- History of immunodeficiency, HIV infection, organ transplantation, or stem cell transplantation
- Autologous stem cell transplantation within 90 days before first dose
- Severe or uncontrolled cardiovascular diseases
- Severe concomitant diseases that pose safety risks or interfere with study completion
- Pregnant or breastfeeding women, or positive pregnancy test at baseline
- History of other cancers diagnosed or treated within the past 5 years
- Any other conditions judged by the investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 cycles of 28 days each
Participants receive the JAK1 inhibitor Golidocitnib orally once daily in 28-day cycles. Treatment continues for up to 24 cycles or until disease progression, lack of response within the first 6 cycles, or intolerable toxicity occurs.
Visits once every cycle during the first year, then every two cycles thereafter
Trial Site Locations
Total: 2 locations
1
Institute of Hematology & Blood Diseases Hospital, China
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
2
Institute of Hematology & Blood Diseases Hospital
Tianjin, China, 300020
Not Yet Recruiting
Research Team
S
Shuhua Yi, Doctor
L
Lugui Qiu, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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