A Phase I/II, Open-Label Clinical Trial to Evaluate the Efficacy and Safety of Golidocitinib As Monotherapy or in Combination with Pomalidomide for the Treatment of Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is a phase I/II clinical trial to evaluate the efficacy and safety of Golidocitinib combined with Pomalidomide for relapsed/refractory peripheral T-cell lymphoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• Patients must demonstrate a comprehensive understanding of the study protocol, voluntarily consent to participation, and execute the informed consent document.

• Inclusive of both genders, participants must be aged 18 years or older and not exceed 80 years of age.

• Histopathological confirmation of peripheral T-cell lymphoma (PTCL) must adhere to the World Health Organization (WHO) 2016 classification criteria. This encompasses a range of PTCL subtypes, including but not limited to peripheral T cell lymphoma not otherwise specified (PTCL NOS), vascular immunoblastic T cell lymphoma (AITL), NK/T cell lymphoma, anaplastic large cell lymphoma ALK positive (ALCL ALK+), anaplastic large cell lymphoma ALK negative (ALCL ALK-), enteropathy-associated T-cell lymphoma, hepato-splenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, and other subtypes deemed eligible for study participation by the investigators.

• Subjects must exhibit relapsed or refractory disease following prior systemic therapy, which may include autologous hematopoietic stem cell transplantation. Relapse is characterized by disease recurrence post-complete response (CR), whereas refractory disease is indicated by stable disease (SD) or progressive disease (PD) following systemic chemotherapy, or by the absence of CR upon treatment completion necessitating further intervention.

• At least one lesion must be present that is evaluable or measurable according to the Lugano2014 criteria: for lymph node lesions, the minimum measurable length is 1.5cm; for non-lymph node lesions, extra-nodal lesions must exceed 1.0cm in length.

• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score ranging from 0 to 2.

• Laboratory parameters must meet the following criteria: (1) absolute neutrophil count (ANC) of at least 1.5×10\^9/L; (2) platelet count (PLT) of at least 75×10\^9/L (with a minimum of 50×10\^9/L for patients with bone marrow infiltration); (3) hemoglobin (HB) level of at least 80 g/L; (4) serum total bilirubin (TBIL) not exceeding 1.5 times the upper limit of normal (ULN); (5) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels not exceeding 2.5 times the ULN; (6) serum creatinine (Scr) not exceeding 1.5 times the ULN.

• Participants must not have undergone radiotherapy, chemotherapy, targeted therapy, or hematopoietic stem cell transplantation within the 3 weeks preceding study enrollment.

• Investigators must assess that the subject has a life expectancy of at least six months.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Zhiming Li
lizhm@sysucc.org.cn
86-020-87343009
Time Frame
Start Date: 2025-01-14
Estimated Completion Date: 2026-12
Participants
Target number of participants: 33
Treatments
Experimental: Golicitinib combined with Pomadomide in the treatment of R/R PTCL
Combination therapy: Subjects received Golidocitinib 150 mg orally once daily continuously, plus Pomalidomide at three dose levels (2 mg, 3 mg, 4 mg) orally on days 1-21 of each 28-day cycle. The dose of Pomalidomide will be escalated according to the 3+3 design to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D). The treatment will continue until disease progression, intolerable toxicity, withdrawal of consent, or other criteria for discontinuation are met, with a maximum treatment duration of 2 years.
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov