Golidocitinib Plus CHOP in Newly Diagnosed PTCL

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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral T-cell Lymphoma
• Intervention / Treatment: Drug: Golidocitinib plus CHOP

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Wei Zhang, Dr; Phone Number: +86 010-69155760; Email: vv1223@vip.sina.com

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Chong Wei, Dr; Phone Number: +86 13521760705; Email: QH5035@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: G-CHOP arm

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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recommended phase 2 dose (RP2D) of phase 1 study	Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) will be established according to the incidence of dose-limiting toxicities (DLTs) of escalated doses of golidocitinib	4 weeks since the date of first dose]
complete remission rate (CRR) of the phase 2 study	Treatment responses were assessed according to the 2014 Lugano classification criteria.	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

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, or death from any cause, whichever occurred first.	From date of enrollment until documented disease progression or death of any reason (up to 3 years)
Overall survival	Overall survival was defined as the time from the date of enrollment to the date of death from any cause.	From date of enrollment until documented death of any reason (up to 3 years)
adverse events	Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	From enrollment till 28 days post the last induction cycle
Objective Response Rate (ORR)	The ORR was defined as the proportion of patients with CR or PR.	Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days)

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: PUMCH-NHL-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No