Golidocitinib combined with CHOP for treating newly diagnosed peripheral T-cell lymphoma

A Phase I/II Study of Golidocitinib in Combination with CHOP in Patients with Newly Diagnosed Peripheral T Cell Lymphoma

This study is testing if a new drug called golidocitinib, when combined with standard chemotherapy, can help people who are newly diagnosed with peripheral T-cell lymphoma.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Drugs / interventions: golcadotinib
• Locations: 1 site (Beijing)
• Trial ID: NCT06739265 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of golidocitinib in combination with the CHOP regimen for patients newly diagnosed with peripheral T-cell lymphoma (PTCL). It follows a single-arm, two-stage design, consisting of Phase I and Phase II parts. The Phase I portion aims to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D), while the Phase II portion focuses on assessing the complete response rate (CRR) of the treatment combination. Patients will be monitored for safety and treatment outcomes throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a confirmed diagnosis of one of the PTCL subtypes and measurable lesions.

Not a fit: Patients outside the age range of 18 to 70 or those with non-measurable lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve response rates in patients with newly diagnosed PTCL.

How similar studies have performed: Other studies have explored similar combinations in PTCL, but the specific use of golidocitinib with CHOP is novel.

Eligibility criteria

Inclusion 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 cell lymphoma (ALCL); or (4) other PTCL subtypes considered eligible by the investigator;
* 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 extranodal lesion must have a long diameter \>1.0 cm;
* 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, PLT to ≥50×10\^9/L, and HGB to ≥75 g/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 (LVEF) ≥50% as determined by echocardiography.

Exclusion Criteria:

* 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;

Where this trial is running

Beijing

• Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Wei Zhang, Dr

Conditions Peripheral T-cell Lymphoma