Golidocitinib Combined With GemOx in RR PTCL (NCT07279584) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Golidocitinib Combined With GemOx in RR PTCL
31 participantsStarted 2025-12-20
Plain-language summary
The objective of this study is to evaluate the efficacy and safety of golidocitinib in combination with the GemOx regimen in r/r PTCL
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. fully understood and voluntarily signed the ICF for this study
. aged ≥ 18 years;
. patients with R/R PTCL who have received at least one prior systemic therapy.
. Patients must have at least one measurable lesion by computed tomography (CT)/magnetic resonance imaging (MRI) (longest diameter of lymph node lesions \> 1.5 cm or longest diameter of extranodal lesions \> 1 cm); evaluable lesions: PET-CT examination showed increased local uptake in lymph nodes or extranodal sites (higher than liver) and imaging characteristics consistent with lymphoma performance
. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
. Adequate bone marrow function, renal function, liver function: ANC ≥ 1.0 × 109/L, hemoglobin ≥ 8.0 g/dL, platelets ≥ 75 × 109/L Note: if the investigator believes that the patient 's above test values are below the lower limit of the protocol due to lymphoma invading the bone marrow, the patient can be enrolled after assessment.Creatinine clearance \> 40 mL/min, calculated by Cockcroft-Gault method: • serum total bilirubin ≤ 1.5 x upper limit of normal (ULN), except for unconjugated bilirubinemia in Gilbert 's syndrome; • ALP (in the absence of bone disease), ALT, and AST ≤ 3.0 × ULN (in the presence of liver metastases, ≤ 5 × ULN); • international normalized ratio (INR) ≤ 1.5 × ULN, or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
. Current negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV), and inactive if positive:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Response Rate
Timeframe: Tumor evaluation was assessed at screening and at the end of treatment (around 3 cycles) then every 12-24 weeks until disease progression (each cycle is 21 days) through study completion, an average of 1 year.
. female patients of childbearing potential had to agree to use a double contraception method at least 28 days before starting study drug, during treatment, and for 6 months after the last dose of study drug, and male patients with partners of childbearing potential had to also use an effective double contraception method during the study and for 3 months after the last dose of study drug, e.g., condom, sponge plug, foam, contraceptive jelly, diaphragm cap or intrauterine contraceptive device, contraceptive pills (oral or parenteral), contraceptive implant (Implanon ®), injectable intravascular injection, or other contraceptive measures.Postmenopausal women (\> 45 years of age and amenorrheic for \> 1 year) and surgically sterile women are exempt from this criterion.
Exclusion criteria
. previously used drugs in the treatment regimen may affect the efficacy evaluation of this study (assessed by the investigator)
. previous bone marrow malignancies, including MDS, AML, MPN, etc.
. and have clinically significant abnormal test results as judged by the investigator;
. inability to be orally administered, previous surgical history or severe gastrointestinal diseases such as dysphagia, active gastric ulcer, etc., which the investigator believes may affect the absorption of the study drug;
. major surgery within 4 weeks before the first study drug administration (referring to grade 3 and 4 surgery as specified in the Measures for the Administration of Clinical Application of Medical Technology implemented on May 1, 2009);
. current clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, congestive heart failure, any grade 3 or 4 heart disease defined by the New York Heart Association functional classification, or a history of myocardial infarction within 6 months after screening.Left ventricular ejection fraction \< 50% measured by echocardiography
. Venous thrombosis or pulmonary embolism within 3 months before study drug administration;
. History of stroke or intracranial hemorrhage within 6 months before the first study drug administration;