Golidocitinib Plus CHOP in Newly Diagnosed PTCL

Official title

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

Overview

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. In the phase I study, a standard "3+3" design will be used. The primary endpoints of the Phase I study are the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D). The primary endpoint of the Phase II study is the complete response rate (CRR) of the golcadotinib combined with CHOP regimen.

Interventions

• Drug Golidocitinib plus CHOP
  Phase 1: dose escalation phase. Drug Golidocitinib: 2 dose level of 150 mg qod and 150 mg qd; CHOP regimen: cyclophosphamide (750 mg/m2 intravenously on day 1), epirubicin (70 mg/m2 intravenously on day 1), vindesine (4 mg intravenously on day 1), and prednisone (60 mg/m2 orally on days 1-5) in a 3-week cycle. Phase 2: dose expansion phase. Drug Golidocitinib: RP2D established in the phase I study; CHOP regimen: cyclophosphamide (750 mg/m2 intravenously on day 1), epirubicin (70 mg/m2 intravenou

Primary outcome measures

• Recommended phase 2 dose (RP2D) of phase 1 study [Time frame: 4 weeks since the date of first dose]]
• complete remission rate (CRR) of the phase 2 study [Time frame: Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days)]

Secondary outcome measures (4)

• Progression-free survival [Time frame: From date of enrollment until documented disease progression or death of any reason (up to 3 years)]
• Overall survival [Time frame: From date of enrollment until documented death of any reason (up to 3 years)]
• adverse events [Time frame: From enrollment till 28 days post the last induction cycle]
• Objective Response Rate (ORR) [Time frame: Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days)]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT06739265 · PUMCH-NHL-018

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗