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New treatment option for Peripheral T-cell Lymphoma
Official title Golidocitinib Plus CHOP in Newly Diagnosed PTCL
ClinicalTrials.gov ID: NCT06739265
What this study is testing
What is Golidocitinib plus CHOP?
Golidocitinib plus CHOP is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for peripheral t-cell lymphoma.
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
- This is single-arm phase I/II study designed to evaluate the safety and efficacy of golcadotinib in combination with the CHOP regimen for patients with newly diagnosed peripheral T-cell lymphoma (PTCL). The study adopts a two-stage design, consisting of a Phase I and a Phase II parts.
- 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 to 70
You may be able to join if
- Age between 18 and 70 years;
- Histopathologically confirmed diagnosis of PTCL of one of the following subtypes: (1) Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)...
- Patients must have at least one measurable lesion according to the Lugano 2014 criteria: For lymph node lesions, the measurable lymph node must have...
- ECOG performance status score of 0-3;
- Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet count (PLT) ≥75×10\^9/L, and hemoglobin (HGB) ≥90 g/L (for...
You likely can't join if
- Extranodal NK/T-cell lymphoma;
- History of acute myocardial infarction or unstable angina, congestive heart failure, symptomatic arrhythmias, or significant QT interval prolongation...
- Uncontrolled active infection;
- ANC ≤0.5×10\^9/L, lymphocyte count ≤0.4×10\^9/L, PLT ≤75×10\^9/L, ALT ≥3 times the ULN, or creatinine clearance ≤50 mL/min;
- Presence of primary or secondary central nervous system (CNS) lymphoma at the time of enrollment;
- Pregnant or breastfeeding women;
See the full eligibility criteria
- Age between 18 and 70 years;
- Histopathologically confirmed diagnosis of PTCL of one of the following subtypes: (1) Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS); (2) Angioimmunoblastic T-cell lymphoma (AITL); (3) Anaplastic large...
- Patients must have at least one measurable lesion according to the Lugano 2014 criteria: For lymph node lesions, the measurable lymph node must have a long diameter \>1.5 cm; for non-lymph node lesions, the measurable...
- ECOG performance status score of 0-3;
- Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet count (PLT) ≥75×10\^9/L, and hemoglobin (HGB) ≥90 g/L (for patients with bone marrow involvement, ANC can be relaxed to ≥1.0×10\^9/L...
- Adequate organ function: alanine aminotransferase (ALT) \<3 times the upper limit of normal (ULN), total serum bilirubin (TBIL) ≤1.5 times ULN, creatinine clearance ≥50 mL/min, and left ventricular ejection fraction...
- Extranodal NK/T-cell lymphoma;
- History of acute myocardial infarction or unstable angina, congestive heart failure, symptomatic arrhythmias, or significant QT interval prolongation (men \>450 ms, women \>470 ms) within the past 6 months;
- Uncontrolled active infection;
- ANC ≤0.5×10\^9/L, lymphocyte count ≤0.4×10\^9/L, PLT ≤75×10\^9/L, ALT ≥3 times the ULN, or creatinine clearance ≤50 mL/min;
- Presence of primary or secondary central nervous system (CNS) lymphoma at the time of enrollment;
- Pregnant or breastfeeding women;
- Patients who have received any investigational drug or radiotherapy within the past 4 weeks;
- Individuals deemed unsuitable for participation by the investigator;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.