Lymphoma, T-CellPhase 2NCT06716658
JAK1 Inhibitor Golidocitnib for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
A Phase 2 study testing JAK1 Inhibitor in people with Lymphoma, T-Cell and NK-LGL Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, NK-LGL Leukemia, T-LGL Leukemia
- What is being tested?
- JAK1 Inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesChina
- Study dates
- 25 Dec 2024to 15 Nov 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, with no restrictions on gender;
- Histologically confirmed relapsed/refractory (R/R) indolent T/NK-cell; lymphoma that has failed at least one systemic therapy or is intolerant to such treatment and/or currently has no effective standard treatment options;
- The patient meets the criteria for appropriate therapeutic indications;
- ECOG performance status of 0-2;
- Adequate organ function, defined as: Total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; Blood urea nitrogen (BUN)/Urea and creatinine (Cr) ≤ 1.5 × ULN; Left ventricular ejection fraction (LVEF) ≥ 50%; Fridericia-corrected QT interval (QTcF): < 450 ms for males, < 470 ms for females;
- An expected survival time of at least 3 months;
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- Male and female subjects of childbearing potential must agree to use effective contraception throughout the study period and for 6 months after the last dose of the investigational drug;
- A washout period of ≥ 4 weeks since receiving any prior antitumor therapies (including radiotherapy, chemotherapy, hormone therapy, surgery, or molecular targeted therapy) before participating in this study;
- The subject has not participated in any other clinical trial within 1 month prior to enrollment;
- The subject agrees to and signs the informed consent form.
Who cannot join
- Subjects who have previously used any JAK inhibitors;
- Subjects with clinical conditions such as dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and/or absorption of the study drug;
- Subjects with active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
- Subjects with HBV or HCV infections, defined as HBsAg and/or HBcAb positivity and HBV DNA copy number ≥ the upper limit of normal (ULN), or acute or chronic active hepatitis C (HCV antibody-positive);
- Subjects with a history of immunodeficiency, including those who are HIV-positive, or those with other acquired or congenital immunodeficiency diseases, a history of organ transplantation, or a history of allogeneic bone marrow or hematopoietic stem cell transplantation;
- Subjects who have undergone autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study treatment;
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- Subjects with severe or uncontrolled cardiovascular diseases;
- Subjects with severe concomitant diseases that pose a significant risk to patient safety or, in the investigator's judgment, may interfere with the completion of the study (e.g., uncontrolled hypertension, diabetes, or thyroid disorders);
- Pregnant or breastfeeding female subjects, or baseline positive pregnancy test results in women of childbearing potential;
- Subjects with a history of other malignancies diagnosed or treated within the past 5 years;
- Any other conditions that, in the investigator's opinion, render the subject unsuitable for participation in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital, China
Tianjin, Tianjin Municipality, 300020
Shuhua Yi, Doctor, 86-22-23909106, yishuhua@ihcams.ac.cn
Lugui Qiu, Doctor, 86-22-23909172, qiulg@ihcams.ac.cn
- Not yet recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, 300020
About this study
Official title: Exploratory Clinical Study of JAK1 Inhibitor Golidocitnib in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial
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.
Read the detailed description
Plan to enroll 48 patients with relapsed/refractory indolent T/NK-cell lymphomas; they will receive JAK1 inhibitor treatment (Golidocitnib150mg QD orally, with a 28-day cycle). Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first.
- Conditions
- Lymphoma, T-Cell, NK-LGL Leukemia, T-LGL Leukemia, Cutaneous T Cell Lymphoma, Cutaneous T Cell Lymphoma (CTCL), Large Granular Lymphocyte Leukemia
- Being tested
- JAK1 Inhibitor
- Keywords
- Indolent T/NK-cell lymphomas, JAK1 inhibitor
- Medical subject headings
- Lymphoma, T-Cell, Leukemia, Large Granular Lymphocytic, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAK1 InhibitorDrug
Golidocitnib 150mg QD orally, with a 28-day cycle. Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first
| Study group | Role | What they receive |
|---|---|---|
| JAK1 inhibitor | Experimental | Golidocitnib 150mg QD orally Receives: Drug: JAK1 Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
complete remission rate + partial remission rate
Measured: up to 5 years
Secondary outcomes (7)
The safety of JAK1 inhibitor
Incidence of adverse events, serious adverse events and significant adverse event
Measured: up to 5 years
Complete remession rate
Hematological PR was defined as an improvement in blood counts ANC > 0.5 × 109/L; HGB increased by >1 g/dL; PLT > 50 × 109/L
Measured: up to 5 years
Duration of remission
the time from response to progression/death (P/D)
Measured: up to 5 years
Time to response
from the start of treatment to the first observed partial remission
Measured: up to 5 years
Progression-free survival
the time from treatment initiation until disease progression or death
Measured: up to 5 years
Overall survival
The time from the start of treatment to the patient's death from any cause
Measured: up to 5 years
Disease control rate
the proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage of patients who achieve complete response (CR), partial response (PR), and stable disease (SD).
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start25 Dec 2024
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-CellStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin First Central Hospital, The First Affiliated Hospital of Air Force Medical University, The First Hospital of Jilin University, The First Affiliated Hospital of Nanchang University, Henan Cancer Hospital, Second Xiangya Hospital of Central South University, Tongji Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716658
- Sponsor's protocol ID
- IIT2024084
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of JAK1 Inhibitor Golidocitnib in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial
- ClinicalTrials.gov ID
- NCT06716658
- Acronym / sponsor ID
- IIT2024084
- Conditions
- Lymphoma, T-Cell, NK-LGL Leukemia, T-LGL Leukemia, Cutaneous T Cell Lymphoma, Cutaneous T Cell Lymphoma (CTCL), Large Granular Lymphocyte Leukemia
- Keywords
- Indolent T/NK-cell lymphomas, JAK1 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Tianjin First Central Hospital, The First Affiliated Hospital of Air Force Medical University, The First Hospital of Jilin University, The First Affiliated Hospital of Nanchang University, Henan Cancer Hospital, Second Xiangya Hospital of Central South University, Tongji Hospital
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2028 (estimated)
- First posted
- 4 Dec 2024 (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.
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.
Detailed description
Plan to enroll 48 patients with relapsed/refractory indolent T/NK-cell lymphomas; they will receive JAK1 inhibitor treatment (Golidocitnib150mg QD orally, with a 28-day cycle). Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JAK1 inhibitor | Experimental | Drug: JAK1 InhibitorGolidocitnib 150mg QD orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years, with no restrictions on gender;
- Histologically confirmed relapsed/refractory (R/R) indolent T/NK-cell; lymphoma that has failed at least one systemic therapy or is intolerant to such treatment and/or currently has no effective standard treatment options;
- The patient meets the criteria for appropriate therapeutic indications;
- ECOG performance status of 0-2;
- Adequate organ function, defined as: Total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; Blood urea nitrogen (BUN)/Urea and creatinine (Cr) ≤ 1.5 × ULN; Left ventricular ejection fraction (LVEF) ≥ 50%; Fridericia-corrected QT interval (QTcF): < 450 ms for males, < 470 ms for females;
Key exclusion criteria (11 listed)
- Subjects who have previously used any JAK inhibitors;
- Subjects with clinical conditions such as dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and/or absorption of the study drug;
- Subjects with active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
- Subjects with HBV or HCV infections, defined as HBsAg and/or HBcAb positivity and HBV DNA copy number ≥ the upper limit of normal (ULN), or acute or chronic active hepatitis C (HCV antibody-positive);
- Subjects with a history of immunodeficiency, including those who are HIV-positive, or those with other acquired or congenital immunodeficiency diseases, a history of organ transplantation, or a history of allogeneic bone marrow or hematopoietic stem cell transplantation;
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 |
|---|---|---|
| JAK1 InhibitorGolidocitnib 150mg QD orally, with a 28-day cycle. Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first | Drug | JAK1 inhibitor |
Primary outcome
Overall response rate
Time frame: up to 5 years
complete remission rate + partial remission rate
7 secondary outcomes
The safety of JAK1 inhibitor
Time frame: up to 5 years
Complete remession rate
Time frame: up to 5 years
Duration of remission
Time frame: up to 5 years
Time to response
Time frame: up to 5 years
Progression-free survival
Time frame: up to 5 years
Overall survival
Time frame: up to 5 years
Disease control rate
Time frame: up to 5 years
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 18 Nov 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JAK1 Inhibitor in people with Lymphoma, T-Cell and NK-LGL Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 2 sites in 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 10 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Shuhua Yi, Doctor (86-22-23909106, yishuhua@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: up to 5 years). 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 18 Nov 2025.