Actively Recruiting
JAK1 Inhibitor Golidocitnib for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-11-18
48
Participants Needed
2
Research Sites
203 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 heterogeneous group of lymphoproliferative diseases originating from T/NK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T/NK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed/refractory indolent T/NK-cell lymphomas. Patients will be treated with Golidocitnib, with an expected overall response rate of 60% for JAK1 inhibitor Golidocitnib treatment.
CONDITIONS
Official 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, any gender
- Histologically confirmed relapsed or refractory indolent T/NK-cell lymphoma after at least one systemic therapy or intolerant to such treatment
- Suitable for the study treatment according to medical evaluation
- ECOG performance status between 0 and 2
- Adequate organ function including normal liver enzymes, kidney function, heart function (LVEF ≥ 50%), and QT interval within specified limits
- Expected survival of at least 3 months
- Agreement to use effective contraception during the study and for 6 months after the last dose if of childbearing potential
- At least 4 weeks since any prior antitumor therapy
- 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
- Conditions like difficulty swallowing, malabsorption, or chronic gastrointestinal diseases affecting drug intake or compliance
- Active infections requiring treatment, including viral, bacterial, or fungal infections
- Positive for hepatitis B or C infections with active viral replication
- History of immunodeficiency including HIV infection or history of organ or bone marrow transplant
- Autologous hematopoietic stem cell transplant within 90 days before first study dose
- Severe or uncontrolled cardiovascular diseases
- Severe other diseases posing safety risks or interfering 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 condition that the investigator judges unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
L
Lugui Qiu, Doctor
CONTACT
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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