BridgeMD
New treatment option for Lymphoma, T-Cell
Official title JAK1 Inhibitor Golidocitnib for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas
ClinicalTrials.gov ID: NCT06716658
What this study is testing
What is JAK1 Inhibitor?
JAK1 Inhibitor is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for lymphoma, t-cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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)...
You likely can't join if
- people who have previously used any JAK inhibitors;
- people with clinical conditions such as dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance...
- people with active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
- people 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...
- people with a history of immunodeficiency, including those who are HIV-positive, or those with other acquired or congenital immunodeficiency...
- people who have undergone autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study treatment;
See the full eligibility criteria
- 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...
- 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%...
- An expected survival time of at least 3 months;
- Male and female people 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.
- people who have previously used any JAK inhibitors;
- people with clinical conditions such as dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and/or absorption of the study drug;
- people with active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
- people 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);
- people 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...
- people who have undergone autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study treatment;
- people with severe or uncontrolled cardiovascular diseases;
- people 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...
- Pregnant or breastfeeding female people, or baseline positive pregnancy test results in women of childbearing potential;
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China; Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.