Phase
Condition
Lymphoma
Non-hodgkin's Lymphoma
Treatment
Golicitinib combined with Pomadomide
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 notexceed 80 years of age.
Histopathological confirmation of peripheral T-cell lymphoma (PTCL) must adhere tothe World Health Organization (WHO) 2016 classification criteria. This encompasses arange of PTCL subtypes, including but not limited to peripheral T cell lymphoma nototherwise specified (PTCL NOS), vascular immunoblastic T cell lymphoma (AITL), NK/Tcell lymphoma, anaplastic large cell lymphoma ALK positive (ALCL ALK+), anaplasticlarge cell lymphoma ALK negative (ALCL ALK-), enteropathy-associated T-celllymphoma, hepato-splenic T-cell lymphoma, subcutaneous panniculitis-like T-celllymphoma, and other subtypes deemed eligible for study participation by theinvestigators.
Subjects must exhibit relapsed or refractory disease following prior systemictherapy, which may include autologous hematopoietic stem cell transplantation.Relapse is characterized by disease recurrence post-complete response (CR), whereasrefractory disease is indicated by stable disease (SD) or progressive disease (PD)following systemic chemotherapy, or by the absence of CR upon treatment completionnecessitating further intervention.
At least one lesion must be present that is evaluable or measurable according to theLugano2014 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) performancestatus score ranging from 0 to 2.
Laboratory parameters must meet the following criteria: (1) absolute neutrophilcount (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) notexceeding 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 studyenrollment.
Investigators must assess that the subject has a life expectancy of at least sixmonths.
Exclusion
Exclusion Criteria:
Presence of hemophagocytic syndrome.
Involvement of the central nervous system or meninges by lymphoma.
A history of malignant tumors within the past five years, with the exception oflocally curable tumors that have been subjected to radical treatment (e.g., basal orsquamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma insitu of the prostate, cervix, or breast).
History of any of the following treatments:(1) Allogeneic hematopoietic stem celltransplantation prior to the administration of the investigational drug; (2)Autologous hematopoietic stem cell transplantation within six months preceding studydrug administration; (3) Previous use of golidocitinib or pomalidomide; (4) Currentuse of vitamin K antagonists, antiplatelet drugs, anticoagulants (or unable todiscontinue within one week prior to study commencement); (5) Requirement forsystemic glucocorticoid therapy or other immunosuppressive therapy for any conditionwithin 14 days prior to study initiation; topical, ocular, intraarticular,intranasal, and inhaled glucocorticoids are permitted; short-term (≤7 days)glucocorticoid use for prophylactic treatment or non-autoimmune diseases is allowed; (6) Cytotoxic chemotherapy must not have been terminated within 21 days before thestart of the study; (7) Received systemic antineoplastic therapy (includingmacromolecular monoclonal antibodies and immunotherapy drugs) within four weeks ofstudy initiation; (8) Undergone major surgery (excluding vascular access surgery) orexperienced serious trauma within four weeks before the start of the study; orreceived radiation therapy within three weeks; (9) Received othertoxin/isotope-immune antibody conjugates within ten weeks; (10) For other types ofnew drug use, the researcher shall make a determination after comprehensiveassessment; (11) Received an experimental drug or investigational drug in anothertrial within 30 days prior to study commencement; (12) Received live vaccines (except attenuated influenza vaccines) 28 days prior to study drug administration.
Active infections, including: (1) Known active/latent tuberculosis, including apositive tuberculin skin test or findings on plain chest X-ray/CT (positive skintest results should exhibit an induration diameter greater than 10 mm, or as perlocal clinical criteria); (2) Known history of Human Immunodeficiency Virus (HIV)infection and/or acquired immunodeficiency syndrome; (3) Patients with activechronic hepatitis B or hepatitis C. Hepatitis B Surface Antigen (HBsAg) must befurther tested with Hepatitis B Virus (HBV) DNA titer (not to exceed 1000 IU/mL) atthe screening stage. Enrollment in the trial is only possible after excluding activehepatitis B or C infections requiring treatment. Hepatitis B carriers, patients withstable hepatitis B after drug treatment (with a DNA titer not exceeding 1000 IU/mL),and cured hepatitis C patients are eligible for enrollment. (For included hepatitisB patients, entecavir and other anti-hepatitis B virus treatments should beadministered orally as per guidelines); (4) Active viral infections other thanhepatitis B and C (e.g., herpes zoster, cytomegalovirus); (5) Infectionsnecessitating oral or intravenous antimicrobial therapy; (6) Bacterial infectionswithin 30 days, including pneumonia.
Active autoimmune diseases requiring systemic treatment within the past two years (hormone replacement therapy not considered systemic treatment, such as type Idiabetes, hypothyroidism managed with thyroxine replacement alone, adrenal orpituitary insufficiency requiring only physiological glucocorticoid replacement);patients with autoimmune diseases not requiring systemic treatment in the past twoyears may be enrolled.
Uncontrolled cardiac clinical symptoms or diseases, such as: i. New York HeartAssociation (NYHA) class > 2 heart failure ii. Unstable angina pectoris iii.Myocardial infarction within one year iv. Patients with clinically significantsupraventricular or ventricular arrhythmias requiring treatment or intervention;
Prior interstitial lung disease (except for asymptomatic interstitial lung diseaseinduced by radiotherapy).
Presence of unresolved adverse drug reactions greater than CTCAE grade 1 (excludingalopecia) before study initiation.
Patients with hypersensitivity to golidocitinib or pomalidomide/capsule excipientsor other chemical analogs; patients with a known history of severe allergicreactions to monoclonal antibodies (CTCAE≥3) and uncontrolled allergic asthma.
Subjects requiring supportive treatment for refractory nausea, vomiting, chronicgastrointestinal disorders, dysphagia, or prior surgical removal of intestinalsegments that may impede adequate drug absorption.
Pregnant and lactating women and individuals of childbearing age who are unwillingto practice contraceptive measures.
Individuals with psychiatric illnesses or those incapable of providing informedconsent.
Deemed ineligible for study participation by the researcher.
Study Design
Study Description
Connect with a study center
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaActive - Recruiting
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