JAK1 Inhibitor Golidocitnib for the Treatment of Relapsed/refractory Indolent T/NK-cell Lymphomas

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Nov 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Golidocitnib for patients with indolent T/NK-cell lymphomas, which are types of blood cancers that grow slowly but are currently hard to cure. The goal of the study is to see how well this medication works and how safe it is for people whose lymphoma has not responded to previous treatments. To be eligible, participants need to be at least 18 years old, have a confirmed diagnosis of relapsed or refractory indolent T/NK-cell lymphoma, and have tried at least one other treatment that didn't work. It’s important that participants are in relatively good health and can expect to be monitored closely throughout the trial.

Those who join the study will receive Golidocitnib and will be observed for their response to the treatment, with an expected overall response rate of around 60%. Participants will also need to agree to certain health checks and use effective contraception if they are of childbearing potential. The trial is currently recruiting, and the researchers hope to find a promising option for patients who currently have limited treatment choices.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years, with no restrictions on gender;
• • 2. 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;
• • 3. The patient meets the criteria for appropriate therapeutic indications;
• • 4. ECOG performance status of 0-2;
• • 5. 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;
• • 6. An expected survival time of at least 3 months;
• • 7. 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;
• • 8. 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;
• • 9. The subject has not participated in any other clinical trial within 1 month prior to enrollment;
• • 10. The subject agrees to and signs the informed consent form.
• Exclusion Criteria:
• • 1. Subjects who have previously used any JAK inhibitors;
• • 2. 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;
• • 3. Subjects with active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
• • 4. 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);
• • 5. 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;
• • 6. Subjects who have undergone autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study treatment;
• • 7. Subjects with severe or uncontrolled cardiovascular diseases;
• • 8. 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);
• • 9. Pregnant or breastfeeding female subjects, or baseline positive pregnancy test results in women of childbearing potential;
• • 10. Subjects with a history of other malignancies diagnosed or treated within the past 5 years;
• • 11. Any other conditions that, in the investigator's opinion, render the subject unsuitable for participation in the study.