Golidocitinib Plus CHOP in Newly Diagnosed PTCL

NCT06739265 | Recruiting Phase 1

• 1 other identifier: PUMCH-NHL-018
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral T-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Progression-free survival

  From date of enrollment until documented disease progression or death of any reason (up to 3 years)

• Overall survival

  From date of enrollment until documented death of any reason (up to 3 years)

• adverse events

  From enrollment till 28 days post the last induction cycle

• Objective Response Rate (ORR)

  Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days)

Study Arms (1)

G-CHOP arm

EXPERIMENTAL

Drug: Golidocitinib plus CHOP

Interventions

Golidocitinib plus CHOP DRUG

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.

G-CHOP arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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); (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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Wei Zhang, Dr

CONTACT

+86 010-69155760; vv1223@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: December 18, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 18, 2024

Record last verified: 2024-09

Locations

CN (1)